Topical formulations ppt

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It cost an additional $3. When true allergic reactions have been confirmed, the reactions are most commonly the type I anaphylactic and type IV delayed hypersensitivity responses. Conventional formulations for topical and dermatological administration of drugs have certain limitations like poor adherence to skin,poor permeability and compromised patient compliance. Table 1: Pros and cons of different routes of drug administration Route Advantages Disadvantages Oral • Easy • Preferred by patients • “Slow-release” preparations may be available to extend duration of action • Drugs can be formulated in such a way as to protect them from digestive enzymes, acid, etc. Conflict Of Insterest We declare that we have no conflict of interest. The three main parenteral routes of drug administration are IV, IM, and SC, and in all cases administration is usually via a hollow needle. Topical beta blockers are often chosen as first-line medical therapy, but have well-documented systemic side effects that limit their use in infants, in children with reactive airways, and in some with cardiac disease. Topical dermatologic products, which can be administered easily and are convenient in terms of portability, are used in treating a variety of disorders. Otic gels and ointments are used in these formulations and they are applied directly to the skin of the ear. Open in figure viewerPowerPoint. • Polymers enable soft, silky and nonpilling skin feel, allowing for smooth application of API in medicated topicals. In an animal model of meningitis, this characteristic was found to correlate with greater efficacy. g. Such preparations are made when it is difficult to swallow the medicines. An occlusive vehicle enhances penetration of the active ingredient and improves efficacy. One-way analysis of variance (P<0. 1% active ingredient. In 1983, it cost an estimated $8. For example, in 2015, a patient died after using a compounded topical anesthetic cream. Dosage Form Design: Pharmaceutical and Formulation Considerations 4 SECTION II DRUG DOSAGE FORM AND DRUG DELIVERY SYSTEM DESIGN After reading this chapter, the student will be able to: 1. At the most, they represent less than 1% of all adverse local anesthetic reactions. Though, their use is common, there exists a significant confusion among the general public and some medically trained professionals, as to the difference between topical and transdermal products. , in waxes and the phases that are formed). Class. Topical capsaicin formulations are used for pain management. 5) IND-enabling pharmacology, DMPK & toxicology studies: Need to align with clinical route of administration, dose schedules, & duration of treatment. Apply thin film 2 to 3 times a day. Water Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations: no longer than 30 days or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled room temperatures. These formulations range in consistency from solid through semisolid to liquids. The aqueous formulations contain approximately 0. Register Now! chapter 1 Pharmaceutical solutions for oral administration In this chapter we will: examine the types and uses of pharmaceutical solutions as oral drug delivery systems provide an overview of the advantages and disadvantages of pharmaceutical solutions as oral drug delivery systems Velesco’s clinical pharmaceutical formulation development will be suitable for manufacture and for delivering your drug to the patient. Their efficacy may be attributed to multiple mechanisms of action, including their anti-inflammatory, immunosuppressive and antiproliferative effects. 18-20 Compounded topical anes- Topical steroids (Corticosteroids) control inflammation by mimicking naturally occurring corticosteroid hormones produced by our adrenal glands. to demonstrate BE for topical dermatological products. In addition to reducing inflammation (redness and swelling) in the area that they are applied they also suppress the immune response, reduce cell turnover, and constrict (narrow) blood vessels. However, there is In Vitro Evaluations for a New Topical and antioxidant activity, comparing our test product with other formulations of P-3086 where one or more of the Compounded topical anesthetics also are available. As a cosmetic chemist, I love it when an ingredient is multi-functional because I can get more benefits without increasing the cost of my formula. Even though vitamin K1 is not available in United Sates as a topical pharmaceutical product, a vitamin K1 topical cream is manufactured in Slovenia by Pharmadab (with Brand name Reconval K1), which contains 0. gov Evaluation of Topical Gel Bases Formulated with Various Essential Oils for Antibacterial Activity against Methicillin-Resistant Staphylococcus Aureus Marwa H Shukr1* and Ghada F Metwally2 1Department of Pharmaceutics, and 2Department of Plant Tissue Culture, National Organization for Drug Control and Research (NODCAR), Cairo, Egypt Two topical formulations use active ingredients, which they claim can reduce redness in SD, thereby displaying anti-inflammatory properties. However, systemic absorption does occur and varies with the area, site, drug, and state of the skin. 62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations. Tradename (clindamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. , Ph. JAMA Dermatol. The use of this manual requires knowledge based interpretation by healthcare professionals and is intended solely for use by pharmacists in healthcare facilities. ). Before sharing sensitive information, make sure you're on a federal government site. An ideal topical formulation can be produced using a simple, flexible process. J Am Acad Dermatol. This activity is intended for physicians and nurses. Process Validation of Ointment Creams - Free download as Powerpoint Presentation (. Formulation Design of Generic Topical Drug Products 2005-4137S2_04_Lionberger. 05%. Excipient based on their origin5 Animal source: - Lactose, Gelatin, Stearic acid, Bees wax, Honey, Musk, Lanolin etc. There are several methods of achieving therapeutic drug concentrations within the eye and its surrounding structures. , Patel N. Chapter 5 Pharmaceutical formulation and its evaluation 114 level. Advantages of topical drug use in otology: The aim of this study was to evaluate the relationship between dermal microdialysis (DMD) sampling and the dermatopharmacokinetic method when employed simultaneously for bioequivalence (BE) investigations of topical formulations. 8 mm (Palms & soles) 0. A companion chapter, Ophthalmic Preparations—Quality Tests 771 , will address performance tests such as dissolution and drug release. Mechanisms of Drug Absorption. 01%. Atopic dermatitis (AD) (or atopic eczema) is a chronic skin condition that affects the quality of life of both adults and children. The measurement of drug release from a given dosage form is fundamental to drug product development. , J. Egbaria and N. com, find free presentations research about Topical Preparations PPT Target Audience and Goal Statement. Professor Trevor Duke2 Dr Julian Kelly2 Dr Sean Beggs3 A. Register FREE for our regular newsletters now, and enjoy FREE access to feature article content and to the digital versions of Personal Care Magazine. Process Validation of Ointments and Creams Typical Approaches For the Development of Topical Formulations. Topical gel drug administration is a localized drug delivery system anywhere in the body through ophthalmic, rectal, vaginal and skin as topical routes. www. Overall, the clinical evidence indicates that topical gel is a safe and effective treatment The group has utilized different types of microscopy to study overall structure and morphology. Vehicles used for topical formulations. 17-0. Poor permeability of some drugs through the skin. Although histological examination found lymphatic cells in the dermis of skins treated with either gel, the numbers of lymphatic cells were small and FORMULATION AND EVALUATION OF VARIOUS COSMETIC AND DENTAL PRODUCT 1) DEFINITION:- The term cosmetics have been derived from the term “COSMETIKOS” which means the skill to decorate. Loubert 2 1Pion Inc. A. b. Eye drops are instilled directly into the eyes. When you consider softgel solutions 7. As with solid formulations, liquid formulations combine the drug product with a variety of compounds to ensure a stable active medication following storage. Find PowerPoint Presentations and Slides using the power of XPowerPoint. The Scientific World Journal is a peer-reviewed, Open Access journal that publishes original research, reviews, and clinical studies covering a wide range of subjects in science, technology, and medicine. * Author to . Weiner College of Pharmacy, The University of Michigan, Ann Arbor, MI, U. Mechanism of action for the penetration enhancing effect of propylene glycol is hypothesized as by the solvation of keratin with in the stratum corneum by competition with water for hydrogen bonding sites and the intercalation in the polar head groups of the lipid bilayer [28]. Changes in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical minoxidil, placebo, or no Co-management of Cataract Surgery Bill Tullo, OD, FAAO, Dipl CCL&R Vice-President of Clinical Services Cataracts • Each year about 2. Tablets – a tablet is disc-shaped and prepared by compressing a granulated powder in a die of suitable machinery. gov or . the topical formulations that effi-ciently deliver drugs. Basavaraj K. There are three pri-mary mechanisms of topical drug main route of topical drug delivery system. Challenges in Formulations. 76 billion in 2016 and is expected to reach $134. Pharmaceutical formulation development to determine the optimal dosage form, composition and manufacturing route is a fundamental part of pharmaceutical product development. Visual inspection and scoring according to the OECD guideline showed no irritation for both CPT loaded ethosomal and blank gels. Dosage forms include solutions, capsules, tablets, emulsions, suspensions, and semisolids. Federal government websites often end in . These systems form fine emulsions (or micro-emulsions) in gastro-intestinal tract (GIT) with mild agitation provided by gastric mobility. Formulations were applied daily on the volunteers’ Drugs That Can Affect Blood Glucose Levels Generic Name (Brand Name) Diabetes In Control's clinical editors along with a team of pharmacy doctoral students have put together a comprehensive, revised and up-to-date list of "Drugs That Can Affect Blood Glucose Levels. tions represents a key advantage over oral or other formulations. Particle Sciences - Technical Brief: 2009: Volume 10 PDF Version. Conclusion. There is a regulatory expectation that the reason for preservative inclusion, proof of efficacy, safety information, control methods in fi nished product and details of labeling in the fi nished product should all be addressed by the applicant [11]. With these technologies, drug and excipients formulations of poorly absorbed drugs such as some moderately large water soluble drugs and peptides. With the present article we want to give an overview of the current state of MF as a valuable and established topical medication, as well as opposite effect when used in the topical formulations [27]. SilDerm ™ Stretch Mark Repair Cream (SilDerm ™ Ltd, Cheshire, UK) contains active ingredients Registril and Darutoside and is recommended by the manufacturer in treating existing SD. pdf), Text File (. Quality by Design (QbD) for Topical Dermatologic Products *Opinions expressed in this presentation are those of the speaker and do not necessarily reflect the views or policies of the FDA Andre S. raw@fda. written in 2000. While all topical and transdermal compounds are applied to the skin, only the transdermal formulations are designed to penetrate through the skin layer and  The recent recognition of the magnitude of cardiovascular risk of both nonselective nonsteroidal anti-inflammatory drugs and COX-2 selective inhibitors , . Every person, and every pain, is unique: what’s right for one patient may not be effective for you. Raw, Ph. 1 Traditionally considered a disease of the elderly, more recent perceptions of OA reveal a broad spectrum of age and disease severity among patients. pdf), deliver drugs through the skin ( percutaneous Oct 9, 2012 Topical preparations exist in many forms, such as ointments, gels, creams, lotions , solutions, suspensions, foams, and shampoos. They contain one or more active ingredients dissolved or uniformly dispersed in a suitable base and any suitable excipients such as emulsifiers, viscosity-increasing agents, antimicrobial agents Topical agents are used locally, where the medicine is applied on the area being treated. However, em-phasis is placed on tablets. Brufen and Optifen Topical formulations of vitamin K1. When gels and emulsions are used in a combined form, ConferenceSeries Ltd is a renowned organization that organizes highly notable pharmaceutical conferences throughout the globe. Davit, Ph. In certain circumstances the preservative may be incompatible with hydrophilic polymers in the formulation due to an electrostatic interaction. ppt), PDF File (. or an animal model) to screen and optimize topical formulations. For several decades pharmacist have been aware of the need to protect their products against microbial contamination but it is only during the last one or perhaps two decades the serious thought of has been applied to the science of preservation. We hope you enjoy. Pharmaceutical Excipients: A review Shilpa P Chaudhari* and Pradeep S Patil Topical Ointments & Creams. Water-in-oil (w/o) creams, which consist of small droplets of water dispersed in a continuous oily phase, can be used to improve the cutaneous absorption of pharmaceutical agents and to facilitate their penetration through the skin layers . The goal of this activity is to describe the use of topical antibiotics in dermatologic practice, including the organisms involved in these infections, issues of emerging antibiotic resistance, and the uses, advantages, and potential limitations of such therapy. Get the plugin now. Generally in pharmacy, parenteral refers to injection. Many antifungal medications are suitable for both dermatophyte and yeast infections. in cases where demonstration of equivalence with  demic and industrial levels – pertaining to nano-formulations: liposomes. Oral Liquid Preparations. Glossary Terms defined in the glossary appear in bold the first time they are used in The final formulation design is optimized to take into account the pharmacokinetic properties of absorption, distribution, metabolism, and excretion. The control of procedure-related-pain is an integral factor for hospitals trying to attain high patient satisfaction scores. Binders, disintegrants etc. Learn vocabulary, terms, and more with flashcards, games, and other study tools. In the coming years, topical drug delivery will be used extensively to impart better patient compliance. 0% from 2016 to 2022. Topical diclofenac is felt to reduce inflammation by inhibition of the COX isoenzymes and thereby decreasing synthesis of proinflammatory prostaglandins. Moreover, moisturizers help restore skin . 2,3 Because there are no curative or disease-modifying therapies for patients with OA at present new topical formulations have recently been developed to optimize treatment modalities for every patient, skin and clinical situation in order to ensure adherence and improve ‘real life’ efficacy. It has a variety of manifestions the most common of which being erythematous, scaly, well-demarcated plaques. Addresses the clinical use and safety of local anesthetics (topical, infiltrative, and infiltrative tumescent) commonly used in office-based dermatologic surgery for adult and pediatric patients. Topical corticosteroids, particularly high-potency corticosteroids, have been a mainstay in the topical treatment of psoriasis for decades (Bagel 2009). Drug Development & Delivery is a print and online publisher that presents the latest scientific methods in drug development for professionals. Intranasal For alleviation of local symptoms. For example, some topical steroids will be classified one or two strengths higher when moving from cream to  Sep 7, 2015 Topical preparation Dr. CD101 is a novel echinocandin with excellent stability and long-acting pharmacokinetics with fungicidal properties against C. The classification of various colorants including FD&C categories, the lists of colorants and their uses, the description about major colorants widely used in the formulations was discussed here in detail. Basic considerations in the dermatokinetics of topical formulations 425 temperature, formulation compositions etc and are discussed briefly. the other formulations. Oxybutynin is also available as a topical gel (Gelnique®) and transdermal patch (Oxytrol®). Aliyar 2, Robert O. Although rectal and vaginal routes of drug delivery are not common, Kalliopi Dodou examines the design of new formulations that allow easier insertion and retention The rectum and vagina are relatively uncommon routes for drug administration. After topical drop instillation, most of the formulation is lost within minutes. n vitro release testing (IVRT) is used to monitor the release and diffusion of drug products from semisolid dosage forms (1–11) and has long been considered a valuable tool in formulation development. . Otic ointments typically use petrolatum as the base. topical corticosteroids Psoriasis is a common disease in the western world, with a prevelence of between 1 and 3%. S. Fig: Longitudinal section showing layers of skin. Velesco Pharma's experience in developing clinical drug formulations ranges from simple, early phase dosage forms to more complicated, later phase formulations. Drug molecules were either encapsulated in the aqueous space or intercalated into the lipid bilayer; the exact location of a drug in the liposome was controlled by regulating the physicochemical characteristics and the An ideal topical formulation can be produced using a simple, flexible process. Efficacy and Tolerability of LAS41004 Formulations in a Non-occlusive Psoriasis Plaque Test (PPT4) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For the treatment of diseases of body tissues and wounds, the drug has to be maintained at the site of treatment for an effective period of time. INTRODUCTION Drug products topically administered via the skin fall demonstrated with oral or topical formulations • FDA-approved aromatase inhibitors for the treatment of cancer are available • FDA-approved testosterone replacement products are available. Some of them may be of questionable value from the therapeutic stand point, still it is worthwhile knowing about these formulations. Most dermatoses are treated with mid-potency to high-potency formulations; mild formulations are better for mild inflammation and for use on the face or intertriginous areas, where drug formulations, with well characterized impurity profiles. mx 2 Risk management 2. Topical otological preparations are so unique they need to be studied in detail. We can’t teach you that in this short Personalized pain relief from Topical Treatment. Design to identify: PK/PD responses, target organs, dose response, exposure multiples & safety margins What is a topical antifungal medication? A topical antifungal medication is a cream, solution, lotion, powder, gel, spray or lacquer applied to the skin surface to treat a fungal infection. 2 Herbal hair oil Hair is the one of the vital part of our body and it influences the overall appearance of the person. " The main sources appear in the Endnotes. Currently we are bringing forth “23 rd International Conference and Exhibition on Pharmaceutical Formulations” (Formulation 2020) scheduled to be held during July 27-28, 2020 at Zurich, Switerzland. Executive Director, Pfizer Board Member, FDA Alumni Association formulations. Cellulose and Its Derivatives Use in the Pharmaceutical Compounding Practice 145 In compounded medicines, powdered cellulose and microcrystalline cellulose are used as an adsorbent, a suspending agent, a capsule diluent (5-30% and 20-90%, respectively). Article Methods: Topical gel formulations of itraconazole were prepared using Carbopol 940 as a gelling agent with different concentrations. Semi-solid topical preparations • Gels (jellies) are two-component semisolid systems rich in liquid. PPT – Topical drug delivery PowerPoint presentation | free to view - id: 1abc42-ZDc1Z. Topical corticosteroids are generally applied 2 to 3 times a day, but high-potency formulations may require application only once a day or even less frequently. Schalau II 2, Hyder A. Skin Topical drug administration for skin disorders minimizes systemic exposure. Diclofenac has however been the most widely studied in reference to musculoskeletal disorders. Topical formulations contain an active ingredient, often a medication or drug or botanical, and a vehicle. NOEL is the amount of drug in mg that does not have any effect on the human health. Topical corticosteroids (TCS) are the main ointments used for treatment, but there is a risk of side-effects with their use, such as skin thinning. A topical medication is a medication that is applied to a particular place on or in the body. Access the full office-based surgery guideline from JAAD (free access). [5] the evidence available suggests that the rate of permeation of drugs from their formulations and the temporal profiles of such permeation may The tentacles of prescription opioid abuse and addiction reach far. Limited disease can be treated with topical therapies. Topical application a. 05) shows that Artofen delivers significantly more drug into the SC compared to the three other formulations, while Iprogel is the least efficient formulation. 20 In these experiments, the amount of LDH released in the culture media directly correlates with cytotoxicity. to deliver drugs topically (skin being the site of action) or transdermally. Skin irritation is an important property of topical formulations. Pharmaceutical formulation development and contract services for optimisation of formulations for powders, capsules, liquids, solids, inhaled and nasal drug formulations. A topical formulation must be aesthetically pleasing, in addition to being both physically and chemically stable, and this may require numerous excipients. 1,2,3,4 This website and its content is subject to our Terms and Conditions. To our knowledge, cream formulations have never been exploited to improve the absorption of nanoparticles. the effectiveness and availability of the medicament is greatly increased than other topical formulations. • Possibility of allergenic reactions. Chaturvedi College of Pharmacy, Nagpur-440 010, Maharashtra, India Received 30 June 2011; Accepted 17 July 2012 Nanoemulsion and Nanoemulgel as A Topical. The entire state is in crisis, with the 2010 census showing that A lot of dermal and transdermal drug delivery systems have been licensed for manufacture after passing through the regulatory approval and trials as specified by different countries example FDA (United States of America). Conclusions There are many effective topical medications Click here for a complete list of the the Cosmetic Formulation Basics series. 9 billion to treating gastrointestinal side effects of NSAIDs for a total cost of 12. This review is concern with all detail information regarding rational approach to topical formulations, principles of topical permeation and basic components of topical drug delivery systems. unstable and not suitable for topical application. We have developed spray-dried, microencapsulated, and microfluidized formulations. They are mostly coated with inert substances like starch to help them disintegrate in the digestive tract of the patient. Moisturizers are topical formulations that help maintain skin hydration by reduce TEWL. The . Formulation and evaluation of topical herbal gel for the treatment of arthritis in animal model Rajasekaran Aiyalu *, Arulkumaran Govindarjan, Arivukkarasu Ramasamy KMCH College of Pharmacy, Coimbatore, Tamilnadu, India The objective of the study is to formulate and evaluate a topical herbal gel containing Cardiospermum Liquid and Semisolid Formulations. A range of technologies Many current oral extended release systems are of the matrix type, based on hydrophilic polymers. Prajapati M. Topical NSAIDs may exacerbate infectious keratitis. Huber 2, and Gary L. Quizlet flashcards, activities and games help you improve your grades. Topical gel formulations provide a suitable delivery system for drugs because they are less greasy and can be easily removed from the skin10. Gwozdz and Robert W. The rectum offers a relatively constant environment for drug delivery provided the drug is presented in a well absorbable form. Introduction. 13,27 One similarity among the lipid-based amphoter-icin B formulations is the ability of the carrier molecules to decrease renal tubular cell binding, significantly reducing (10-fold–20-fold) the propensity for renal the drug to the surface of the skin. Topical Bioadhesive Formulations The drug delivery systems used in this case are required to adhere to the skin for the purpose of: Collecting body fluids Protecting the skin Providing local or systemic drug delivery Adhesion can be described as the formation of a new mechanical bond between the skin and the adhesive agent. Percutaneous absorption is inversely proportional to molecular weight, which particularly affects the diffusion coefficient. &ndash; A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow. Topical formulations were compounded with the strength of 0. , Billerica, MA, USA; 2Dow Corning Corporation, Midland , MI, USA Abstract. D Director- Division of Chemistry I FDA-CDER-Office of Generic Drugs andre. Advantages of This Route 6,16: Unknown safety of certain ingredients used in topical formulations, either alone or in combination. We are committed to maintaining the highest level of quality. Flavourings can be added. 8 million cataract operations are performed, making it the most common operation in the U. Others are more specific to one or the other type of fungus. INTRODUCTION Topical formulations apply a wide spectrum of preparations both cosmetic and dermatological, to healthy or diseased skin [1]. Therefore, cationic hydrophilic polymers should not be used in conjunction with acidic preservatives in oral solution formulations. Several drugs and formulations are available, as are many combination therapies. Phase 3 The Negotiation Process Section 5 Excipient Supplier-User Negotiation Process: provides guidance on the development of an agreement between the excipient supplier and pharmaceutical user to define excipient quality requirements. topical formulations. • In a typical polar gel, a natural or synthetic polymer builds a three-dimensional matrix throughout a hydrophilic liquid. e. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. Osborne. In these 6 pediatric patients, topical formulations of tofacitinib and ruxolitinib in 1%-2%  Conventional formulations for topical and dermatological administration of drugs developing drug delivery systems meant for topical application to the skin,  Nov 20, 2018 There are multiple medication formulations to provide topical anesthesia. D. In many IRISYS’ R&D services span all stages of pharmaceutical formulation development including preformulation studies and analytical methods development, as well as qualification and validation. The term dosage form can also sometimes refer only to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that (like how it is ultimately configured as a consumable product such as a capsule, patch, etc. Generic Name. According to D & C Act:- Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. Background. • Available in several formulations – Enema (topical), tablet, and capsule • Onset of action depends on the specific product – Ranges from 2-16 hours • Absorption depends on route – Rectal: varies – Tablet and capsule ~ 20-30% • Adverse effects – Headache, GI discomfort , pharyngitis In vitro bioequivalence testing for topical ophthalmic suspension products Darby Kozak, PhD (OGD/ORS) View Recording: Product quality testing for topical ophthalmic suspension products Patricia Onyimba (OPQ/OLDP) View Recording: Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic ophthalmic Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. They have all been developed in the last 20 years in the Applications Laboratories of BASF AG and are in solid, liquid, and semi-solid form. With over 400 world class products, our excipients portfolio covers the entire spectrum of pharmaceutical applications. , P-134a and P-227) have now been developed and are being incorporated in aerosol formulations. Silicone Emulsions and Surfactants – A Review This review, written in two parts, has the objective of supplying a working knowledge of the chemistry of silicone compounds to the practicing chemist. It is determined to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial IRISYS developed topical liposomal formulations that demonstrated enhanced stability of the active pharmaceutical ingredients. Deformulation or reverse engineering of a chemical formulation provides specific information about the composition of formulated products and how these components interact. Safety and modest efficacy of low-concentration capsaicin formulations, which require repeated daily self-administration, are supported by meta-analyses of numerous studies. These include solubilizers, stabilizers, buffers, tonicity modifiers, bulking agents, viscosity enhancers/reducers, surfactants, chelating agents, and adjuvants. View and Download PowerPoint Presentations on Topical Preparations PPT. Since epidermal barrier defect plays an essential part in pathogenesis of AD, moisturizers are generally recommended as The way by which illicit drugs can be administered or taken into the body are numerous. It is established that gel formulations are superior topical formulation for the topical delivery of Ibuprofen over the other two topical formulations, because it gives higher drug release than the cream and ointment formulations. Human and veterinary medicines have not been dealt with in Topical CBD oil offers a natural way to nourish sensitive skin and ease the pain of sore muscles (from the outside in). Lee, Particle Sciences, Inc. In Vitro Release Testing Methods for Semisolid Formulations. Oral NSAIDs - Cost of Adverse Events. Topical Formulations Eugene Cooper, Cooper Consulting Garry T. Jan 9, 2018 Complex Drug Substances and Formulations. 1 x 1 Craiglow, B. Professor Noel Cranswick1,2 1. PPT 7 Exam 4 study guide by akirwen includes 140 questions covering vocabulary, terms and more. Hence inclusion levels should be minimal, consistent with adequate preservation. formulations. iii. Regulatory Approaches for Generic Drugs: BE of Topical Drug Products Barbara M. A high-concentration capsaicin 8% patch (Qutenza™) was recently approved in the EU and USA. 4. Topical Formulations. Brand Name. Topical and inhalation routes are separated into their own routes of administration. It provides advantages, such as avoidance of first-pass meta bolism, patients’ improved compliance, con trolled or sustained release, and A 2-hour incubation time is sufficient because these formulations are to be delivered as topical eye drops into the precorneal pocket. Director, Division of Bioequivalence II Office of Generic Drugs, CDER, FDA PQRI Workshop Evaluation of New and Generic Topical Drug Products March 11-13, 2013 PEG-free W/O emulsifier for topical formulations Ideal for heat-sensitive API Stabilizes and improves sensorial and texture properties: W/O emulsifier for lotions and creams, Excellent for dispersions and apolar oils, Allows hot or cold process The relationships Available online 27 February 2009 between the rheological properties of thixotropic formulations, and their effects on the controlled drug delivery through various routes including oral, topical, ophthalmic, dental and mucosal administration and Keywords: pharmacological efficacies were also discussed. gov means it’s official. As such, the skin is susceptible to various disorders and diseases. Topical formulations Alton Chapter 6 and 38 The skin:its function • Mechanical protection (dermis) Changes over time The outer layer of skin should contain 10-20% water to have the proper elasticity • Protection from Bacteria and viruses, foreign substances Dehydration, radiation • Temperature regulation • Production of vitamin D Thick Ophthalmic Preparations—Quality Tests 771 and will include descriptions of and quality tests for all dosage forms that can be applied in the eye. 6 billion to treat arthritis in the USA. In addition to defining the dosage forms, this section presents the general principles involved in the manufacture of some of them, particularly on a small scale. It was noticed that addition of 20% of Carbopol 934 gel is better than preparations containing 10 and 30%. Most often topical administration means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams, foams, gels, lotions, and ointments. References [1]. Alternatives to P-12 (i. But you don’t need to power through the pain…or the side-effects that come with many of the commercially-available medications. 1-12 The International Continence Society What is 505(b)(2)? The 505(b)(2) new drug application (NDA) is one of three U. The mainstay of topical treatment is topical corticosteroids. Topical preparations exist in many forms, such as ointments, gels, creams, lotions, solutions, suspensions, foams, and shampoos. Oct 12, 2016 However, the synergistic activity between these two metal ions as antimicrobial ingredients has not been evaluated in topical formulations. US FDA Develops science-based regulatory standards that address product complexities and manufacturing issues, reducing the barrier for new generic drug devel-opment and provides new valid and reproducible In Vitro approaches for topical generic product equivalence. In The itching associated with seborrhea, or psoriasis, can be treated with topical corticosteroid formulations. c. Read More about CBD Topicals… Extended-release (ER, LA, XL and XR) formulations are available for oxybutynin (Ditropan XL®), tolterodine (Detrol LA®) and trospium (Sanctura XL®). barrier, preserve skin integrity and appearance, and repair lipid barrier function [12]. Skin is one of the most extensive and readily accessible organs on human body for topical administration and is main route of topical drug delivery system. 1 Introduction The extemporaneous preparation of medicines is associated with a number of potential risks to patients, healthcare staff and their organisation. According to Stratistics MRC, the Global Topical Drug Delivery market is estimated at $89. Topical gel formulations provide a suitable delivery system for drugs because they are less greasy and can be easily removed from the skin 10. Don't miss out on the latest news and technology affecting professionals involved in personal care product design, development and manufacture. Results Out of 200 patients studied 152 (76%) were females and 48 (24%) males, the majority belonging to low income group from urban area. Topical semi-solid dosage forms are normally presented in the form of creams, gels, ointments, or pastes. Compare and contrast the advantages/disadvantages of various drug dosage forms 3. Dosage forms are provided for most of the Pharmacopeial drug substances, but the processes for the preparation of many of them are, in general, beyond the scope of the Pharmacopeia. These findings indicate that 1. The journal is divided into 81 subject areas. Dosage. We offer binders, fillers, disintegrants, sweeteners and other traditional excipients. origin, use in dosage form, and functions they perform as follows 1. Molecules of size larger than 500 Lecture 4 - Topical Drug Delivery Systems - Free download as Powerpoint Presentation (. Pharm. At the same time, we have focused on improving the mildness of formulations. txt) or view presentation slides online. 1% vitamin K1. com - id: 616e19-ODljN ensure the quality and performance of topical and transdermal drug products. , Patel K. Department of Clinical Pharmacology, MCRI, Royal Children’s Hospital, Parkville This can include injections, topical and inhalation routes. Some of the drugs currently available on the market are presented in Table 3. During the test period the subjects were allowed to wash normally, but did not use any other skin care products on their arms. For example, experimental superficial corneal ulcers in rabbits exhibited delayed epithelial healing when treated with diclofenac, flurbiprofen, or prednisolone sodium phosphate in comparison with the controls (Hersh et al 1990). Parenteral Route of Administration and Dosage Forms A drug given parenterally is one given by a route other than the mouth (topical dosage forms are considered separately). The specific technique employed is determined by the dosage form itself and the intended route of delivery. Finally, the potential for an extended duration of effect is a key consideration when choosing drug formulations. Reverse engineering, or deformulation, of chemical formulations, materials and products delivered by experienced analytical industry experts. As at June 30, 2018, we had 53 commercialized generic solid dosage formulations products across the United States, Europe, Canada, Australia and the rest of the world. Generic aclometasone . View Large Image | View Hi-Res Image | Download PowerPoint Slide. Topical Drug Delivery Formulations edited by David W. Since skin care represents the largest market in cosmetics and oil soluble ingredients are often the best performing skin materials, it’s helpful to learn to make emulsions. com. Prescription and Introduction: Various drugs and formulations are used in otological practice. Creams and emulsions are the most diverse and widely used dosage forms for topical dermatological applications. Tioga Research scientists and technologists have extensive experience with all of these formats. We have specialized technologies for formulation development and optimization of oral, topical and parenteral formulations. The artificial membranes such as silicone membrane or even pig ear skin are used to serve the purpose. Salicylic acid is a beta-hydroxy acid, which is a larger molecule than alpha-hydroxy acids (AHAs) and is widely used in topical formulations as a comedolytic and keratolytic agent. Generic versions Synalar 0. Aclovate Cream Aclovate Ointment Generic Brand. albicans (3, 4). Richardson noted that topical formulations using the same API at the same concentration can look vastly different under the microscope, with differences in structure beyond the API (e. Tsinman 1, Gerald K. 5% topical diclofenac may serve as an effective treatment option for patients with neuropathic pain of the PHN or CRPS origin. However, latest findings have revealed that its efficacy is not only limited to the treatment of cardiovascular diseases as it has shown to possess antioxidant activity and plays an important role in apoptosis. • Their one characteristic feature is the presence of a continuous structure providing solid like properties. Powdered cellulose is also used as a thickening agent. It can be orally administered in soft or hard gelatin capsules. solvents/surfactants, can be used for the design of formulations in order to improve the oral absorption of highly lipophilic drug compounds. Most topical formulations developed today, however, are complex and, therefore, require tightly controlled processing parameters. The study involved a 3-week, double-blind, placebo-controlled trial. , and King, B. Topical medications are widely used as prescription or over the counter (OTC) treatments for a variety of conditions. Topical ruxolitinib for the treatment of alopecia universalis. Emulsifier and Delivery of drugs to the skin is an effective and targeted therapy for local dermatological disorders. Amlodipine (AD) is a calcium channel blocker that is mainly used in the treatment of hypertension and angina. Liquid and semisolid formulations are easier to absorb as compared to solid formulations and are can be administered via a variety of routes of administration. Topical corticosteroids have been ranked in terms of potency into four groups consisting of seven classes. Key words: Topical, Ibuprofen, Formulations, In vitro diffusion. Formulations are only included where there is existence of published formulations and associated stability data. 01/05/2012 Topical Quality by design approaches for topical dermatological dosage forms Arunprasad Sivaraman, Ajay K Banga Department of Pharmaceutical Sciences, College of Pharmacy, Mercer University, Atlanta, GA, USA Abstract: The quality of a pharmaceutical dosage form is the foremost criterion during the development of a product. As the innovators of softgel technology , we offer the world’s best trained team to deliver the most comprehensive formulation services. Has an opportunity for 2 different practicals to investigate formulations, one using oil, water and washing up liquid and one to do with alloys. hhs. We have over 75 years of experience solving complex challenges in formulation, solubility, bioavailability, and development. multiparticulate drug delivery systems are especially suitable for achieving controlled or delayed release oral formulations with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time. You may already have experience with oral or parenteral products, but there are challenges and issues which are unique to development of topical formulations. for people over age 65. The release of drug from microparticles Topical NSAIDs delay epithelial wound healing. The rectal routes avoid hepatic first-pass effect. , Tavares, D. Carbopol polymers specifically allows formulations Advanced Drug Delivery Reviews, 5 (1990) 287-300 287 Elsevier ADR 00070 Liposomes as a topical drug delivery system K. , 1985). Browse our best-selling topical cannabis products below — like our CBD ointment, CBD topical cream, and more. 9. Office-based surgery guideline. (2002) ^ a b Price VH, Menefee E, Strauss PC. There are many topical steroids available, and they differ in potency and formulation. Efficacy structed not to apply any topical products such as moisturizers, sunscreens, and anti-aging formulations on the test sites for two weeks before and during the study. Transdermal drug delivery (TDD) is a viable option for systemic delivery of select drugs. Other parameters like organoleptic characteristics, pH, viscosity, stability towards light and refrigeration should also be evaluated. – In vitro approach for Q1 and Q2 formulations •Lidocaine Topical Path – PK study for bioequivalence – Patch size (area) must be the same – Not a topical dermatological product •Local pain relief (different site of action) •Cyclosporine Ophthalmic Emulsion – In vitro approach for Q1 and Q2 formulations Keywords: Emulgel, Luliconazole, Topical drug delivery. Although not as efficacious as oral therapy, topical formulations of JAK inhibitors, including tofacitinib and ruxolitinib ointment and cream in concentrations of 1% to 2%, may have some efficacy in the treatment of AA. Sixty six (33%) patients used potent TCs, 100 Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. There are multiple medication formulations to provide topical anesthesia. Guidance on CMC for Phase 1 and Phases 2/3 Investigational New Drug Applications Charles P. With the present article we want to give an overview of the current state of MF as a valuable and established topical medication, as well as new topical formulations have recently been developed to optimize treatment modalities for every patient, skin and clinical situation in order to ensure adherence and improve ‘real life’ efficacy. Topical lidocaine cream and ointment (both 5%) was investigated in eight healthy human volunteers (four male, four This study examined topical formulations of novel peripheral analgesics containing 2% amitriptyline, 1% ketamine, and a combination of both in the treatment of neuropathic pain. Hydrocortisone and betamethasone are examples of low- and high-potency topical corticosteroids. Here we give a brief overview of the different forms of drug formulation development: Solid Formulations. Our in-house API capability provides us stable source of API supply for availability of these products at competitive prices the investigator were asked about their current use of topical steroids and fairness creams and observations recorded. Consider Rockcastle County, Kentucky, which has a population of slightly more than 16,000 people: One person dies each week from a drug-related overdose, on average. List reasons for the incorporation of drugs into various dosage forms 2. This includes water being added as an ingredient or water is a component of any ingredient used. 5. • It avoids first-pass effects, gastrointestinal irritation. One study The shorter application time used here is probably more realistic for a topical non-steroidal anti-inflammatory drug application. . For Such cytotoxicity may also affect mammalian cells. An Investigation into UV-Curable Gel Formulations for Topical Nail Medicines Laxmi Valji Kerai A thesis submitted for the degree of Doctor of Philosophy University College London School of Pharmacy December 2016 A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. These routes include the oral route, transdermal, inhalation, and intravenous injection. While the paper was written a long while ago the contents are still topical today. ADVANCE TECHNIQUES IN STANDARDIZATION OF HERBAL DRUGS & FORMULATIONS Dr. Lesson on formulations from the analysis section of the new AQA spec. Injectable drugs are usually in the form of solutions or powders, which are mixed with a sterile diluent to render an injectable solution. anme. BASF offers broad portfolio of excipients for topical formulations enabling you to create the ideal skin delivery solution for your gel formulation. For example creams, ointment and lotions are applied topically on the skin. • Oct 20 th, 2017: Topical Dermatological Generic Drug. mil. Tsinman 1, O. The ideal DDS should show a con-stant zero-order release rate, as this has the potential to create constant plasma concentrations. Intravaginal For infections or contraceptives. spectrophotometrically at 221 nm. The vehicle itself may have a cooling, drying, emollient, or protective action. The vehicle usually contains water, oil, alcohol or propylene glycol mixed with preservatives, emulsifiers, absorption promoters and fragrances. The main challenge of all the different parenteral dosage forms is to achieve a good compatibility of the drug substances with the excipients (no formation of new impurities either by degradation of the drug substance or formation of new chemical entity between the drug substance and the excipients) as well as the compatibility of the preparations with the primary Subjects tolerated topical diclofenac therapy without any side effects or complications. Aclometasone 0. PowerPoint Presentation: “ The topical gel formulation offers an interesting alternative for achieving systemic drug effects of parental routes, which can be inconvenient for oral route, which can result in nausea, vomiting, low bioavailability and passes the hepatic first-pass metabolism. Product Links (if available) Mild Steroid. L. d. A selection of about 500 formulations of human and veterinary drugs are presented in this booklet. Four different Oral and topical administration Medical nail lacquers Such dosage form contains antifungal drugs for topical treatment of onychomycosis Example: Batrafen nail lacquer 8 % Loceryl nail lacquer 8 % Medical shampoo Selected topical formulations for the treatment of seborrheic dermatitis are: Nizoral shampoo Selsun shampoo Sterile dosage forms for True allergic reactions to local anesthetics are rare adverse reactions. , Patel M. G. Thus cosmetics is the art of decorating yourself to look beautiful. In order for topical emulsions to function effectively they require certain functional excipients. The professional use of topical preparations is one of the core competencies in dermatology. Class I topical corticosteroids are the most potent and Class VII are the least potent. 1,18 Two of the more common formulations contain 20 percent lidocaine, four percent tetracaine, and two percent phenylephrine or 10 percent lidocaine, 10 percent prilocaine, four percent tetracaine, and two percent phenylephrine. By far the most common is topical administration but, when higher concentrations of the drug are required, local injection or systemic administration is considered. Review of Paediatric formulations for the 14th WHO Model Essential Medicine List Focus on parenteral, inhalational and topical preparations 25th June 2007 Dr Emma Magrath1 A. • Can be  The Topical/Transdermal Ad Hoc Advisory Panel for the USP Performance Tests of all formulations applied to the skin except transdermal delivery systems  Lecture 4 - Topical Drug Delivery Systems - Free download as Powerpoint Presentation (. As mentioned by Shah et al. Topical corticosteroids are one of the oldest and most useful treatments for dermatologic conditions. 01% (solution) Apply thin film 2 to 4 times a day Salicylic acid is an organic acid that has a colorless crystalline structure and is poorly soluble in water. Osteoarthritis (OA) is a potentially debilitating disorder that can place serious limitations on patient functionality and overall quality of life. Antioxidants — Playing the star and supporting roles in cosmetic formulations. Topical drug delivery systems include a large variety of pharmaceutical dosage form like semisolids, liquid preparation, sprays and solid powders. Most widely used semisolid preparation for topical drug delivery includes gels, creams and ointments. 1 Advantages of Nanoemulgel A stable nanoemulsion formulation is enhanced through nanoemulgel, by decreasing surface and interfacial tension and which leads the viscosity of the aqueous phase to be increased [18]. ppt. • Thickening, suspending and emulsifying properties result in topical formulations that exhibit excellent aesthetics and skin feel. All the prepared emulgel formulations were found to be stable upon storage for 3 months, no change was observed in their physical appearance, pH, rheological properties and drug content. Hoiberg, Ph. The table below describes different formulations. Skilled in the development of pharmaceutical formulations for oral, topical and injectable dosage forms, our formulation development group brings significant experience performing risk assessment and statistically designed experimentation to identify the quality attributes that impact the clinical performance and safety of formulations, manufacturability of dosage forms and stability in identified at the time of its completion. The Adobe Flash plugin is needed to view this content. Products: Overcoming Barriers to  Nov 23, 2016 Cited by: 3. 45 3. The aim of present work was to develop a semisolid preparation (ointment, gel, cream) of Thiocolchicoside which is a cen-trally acting skeletal muscle relaxant for the effective treatment of Topical formulations, such as gels, creams, and ointments, represent a small but significant overall fraction of marketed pharmaceutical products. 5 billion. A simple scheme for a topical formulation is an active pharmaceutical ingredient dissolved or dispersed into a carrier base with selected excipients to achieve the desired stability and functionality. Tes Global Ltd is registered in England (Company No 02017289) with its registered office at 26 Red Lion Square London WC1R 4HQ. Start studying PPT ch4 chr. This advance-ment in skin biology has fueled the development of novel vehicles that have advanced dermatologic thera-py with both new formulations of old drugs and new drug entities. International Journal of Pharmaceutics 315 (2006) 52–58 Microemulsion-based hydrogel formulation of ibuprofen for topical delivery Huabing Chen a , Xueling Chang a , Danrong Du b , Jin Li a , Huibi Xu a , Xiangliang Yang a,∗ a College of Life Science and Technology, Huazhong University of Science and Technology, 430074 Wuhan, China b Chemistry Department, Huazhong University of Science and Pharmaceutical Compounding and Dispensing focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples. IVRT has also been used to screen formulations to select promising candidates, (12–16) and, importantly, accepted for use Typical formats for topical formulations include ointments, lotions, creams, solutions, gels and foams. Formulation and evaluation of herbal gel Ganesh Misal1*, Gouri Dixit2 and Vijay Gulkari1 1Department of Pharmacognosy, 2 Department of Pharmaceutics, J. Because of the somewhat vague boundaries and functions they perform in the formulations e. Administration of topical anesthetics to control pain associated with  Formulation And Evaluation of Topical Aceclofenac Gel Using Different Gelling Agent, JAPAN PATEL, BRIJESH PATEL, HARDEEPSINGH BANWAIT, KAUSHAL   Oct 18, 2018 Medicinal products for cutaneous use, topical products, locally applied . Following are five critical process parameters (CPPs) and additional strategies [4]. Most of these formulations present analytical challenges to those who must develop methods to test them. formulations]; apply to affected area once or twice daily for 2 weeks in tinea versicolor [Canadian/prescription formulation] Gel: Apply to affected area once daily for 7 days [OTC formulations] Solution: Apply to affected area once daily for 7 days in tinea corporis and tinea cruris [OTC An important applications of pharmaceutical emulsions is skin therapy. Go to the guideline Guideline highlights. The term topical drug products refers to all formulations applied to the skin except transdermal delivery systems (TDS) or transdermal patches that will be addressed separately. The objective of this study was to evaluate the efficacy of topical CD101 formulations in a rat model of recurrent VVC. can say that the colorants are the cosmetics for the pharmaceutical formulations. Home; The page is under construction! Topical NSAIDs Various formulations of topical diclofenac are available, including Voltaren gel, Pennsaid solution, and Flector patch, and are used in the setting of osteoarthritis or musculoskeletal pain. It has become common practice in developing drug formulations to consult the FDA’s Inactive Ingredient Guide (IIG) to obtain information on “acceptable levels” of excipients used in previously approved products. Methods NOEL is “No Observed Effect Level” of any pharmaceutical drug. Since January 1996, worldwide production of these CFCs has been reduced to only the amount needed for aerosols used in the treatment of asthma and chronic obstructive pulmonary disease. Topical anesthesia is gaining more popularity and utilization especially with the increased number of out of operating room procedures. From a US regulatory perspective, a topical drug product that conforms to a monograph might be suitable for marketing as an OTC product. Fluocinolone 0. 58 billion by 2022 growing at a CAGR of 7. D Department of Pharmaceutics Faculty of Pharmacy Omer Al-Mukhtar  Aug 7, 2015 STOP GETTING RIPPED OFF! LEARN THE SHOCKING TRUTH ABOUT ACNE, DRUGS, CREAMS AND THE ONLY PATH TO LASTING ACNE  Mar 6, 2014 forms of topical medicines by Belton Winford. A good topical formulation should be one in which the dosage form has both physical and chemical stability and cosmetic acceptability and that also provides the optimal environment for the active ingredients to reach the skin (Block, 1996; Davis et al. comparisons between topical formulations have been minimally evaluated [23]. Unknown potential for systemic absorption and toxicity, particularly if there is excessive application or enhanced absorption of an ingredient. Triton X-100 Factors to consider when choosing a topical preparation: Always consider the effect of the vehicle. Satish Nayak Principal Bansal College of Pharmacy Bhopal PowerPoint Presentation: PROBLEMS WITH MODERN DRUGS High cost (upwards of $ 2000 million) and long time (15-20 yrs) taken in development of new drugs. Transdermal Drug Delivery Structure, Function & Topical treatment of Human Skin Anatomy & Physiology The epidermis 0. Appropriateness • “Primary indication for surgery is when visual The results of the OTC Drug Review were OTC drug monographs – a kind of "rule book" of conditions for each therapeutic category covering acceptable ingredients, uses (indications), doses, formulations, labeling, and testing. Application of Skin PAMPA to Differentiate Between Topical Pharmaceutical Formulations of Ibuprofen K. Fig: Longitudinal section showing layers of skin Advantages of This Route: • It provides a largest surface area. formulations, i. NanjwadeM. Formulations that overcome these three challenges have great clinical potential as a viable alternative to conventional eye drops. They are two-phase systems typically containing hydrophilic ingredient in an aqueous phase and lipophilic ingredients in an oil phase. Eye For desired local effects. Integrating the latest insights with established principles, this important book guides readers in the development of highly effective, nontraditional topical drug delivery formulations. Following are five critical process parameters (CPPs) and additional strategies to optimize the manufacturing process for topical dosage A Review on Pharmaceutical Gel. However, developing an appropriate topical formulation is a complex and challenging process. This review presents considerations which can be employed during the development of a semi-solid topical generic product. Also Soft-Gelatin Technology Capsugel uses soft-gelatin capsule technology, as well as liquid-filled hard capsules, to bring a number of formulation and commercial benefits to biopharmaceutical and health & nutrition customers. 006 mm eyelids. When developing topical products, there are three development phases that must be undertaken to ensure that the finished product will perform optimally when applied to the skin. Parenteral CSPs also offer the advantage of localized delivery of drugs, as with intra-articular administration of corticosteroids in patients with rheumatoid arthritis. topical formulations ppt

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