University of Pittsburgh



DOSAGE FORM DESIGN AND DELIVERYSTUDY GUIDE FOR EXAM 1 (12 Feb 2018)Exam 1 will include 50 multiple choice questions based on the topics in the following table. Each question will be worth 2 points. Please bring a calculator for Exam 1 as some questions may involve calculations. Relevant equations to solve the problems will be provided. This is an in-class, closed book examination. Standard/traditional calculators without internet / wi-fi capability may be used. However, use of laptop computers, smart phones, and all other devices is strictly prohibited during the exam.Important focus areas for each topic and distribution of questions are as follows:TopicFocus areas and level of details to knowQuestions per topicNew drug development processUnderstand the drug development process, Know about different stages in drug development & clinical trials phases Know about need of dosage form, factors influencing dosage form design3-5Drug physicochemical properties and preformulationKnow about importance of preformulation – Understand the effect of various physical & chemical properties of drug on formulation development process3-6Pharmaceutical and formulation considerationsUnderstand the importance of excipients in dosage form design Know about various routes of administration, their advantages, disadvantages and dosage forms associated with each route3-6Biopharmaceutical and pharmacokinetic considerationKnow about bioavailability & bioequivalence, how they influence the choice of dosage form Understand the factors affecting bioavailability of a drug from dosage formUnderstand BCS classification and it’s use in product development3-6CapsulesKnow about Hard gelatin capsules- capsule sizes, materials used for empty capsule, capsule parts, characteristics of empty capsulesVarious excipients and their role in hard capsules, representative excipient examples from each categoryFill materials in hard capsulesUnderstand the differences between hard and soft capsules, their advantages and disadvantagesKnow about various fill materials in soft capsules Various components in softgel capsules & their impact on formulation developmentBe able to choose hard / soft capsule dosage form based on fill material characteristics Quality standards for capsules4-6Immediate release tabletsUnderstand the advantages & disadvantages of tablet dosage formUnderstand the role of different tablet excipients Know the importance of various excipient categories in tablet manufacture and know 1 or 2 examples of widely used materials from each category of excipients. Be able to categorize widely used excipients from inactive ingredients list of a commercial product.Know about different methods of tablet manufacture & steps involved in them, Know about importance of tablet coatingQuality standards for tablets3-6Importance of powder properties in tablets and capsulesKnow about different properties of powders that influence tablet / capsule formulation development Understand importance of particle size & distribution, methods used for size determination, Understand the importance of particle shape, surface area and porosity.Know about different particle densities and importance of bulk density.Understand importance of powder flow, factors affecting flow & methods of measuring flow.3-6Fate of tablet / capsule upon oral administrationKnow about fate of tablet / capsule upon administration- drug release to absorptionKnow about the importance of dissolution testing- USP dissolution apparatus, medium & methodKnow about Noyes Whitney equation for dissolution & factors affecting dissolutionUnderstand the Fick’s 1st & 2nd law of diffusion, passive diffusion & sink conditionKnow about permeability and its importance in drug absorption, apparent permeability3-6Modified Release (MR) dosage forms: Need and design considerationsKnow about rationale of choosing modified release (MR) dosage form, their advantages & disadvantagesHow to choose a drug candidate for MR dosage formBe able to choose appropriate MR dosage form based on drug candidate properties or compliance issuesKnow about 2 different release mechanisms from MR dosage forms & dosage form choices3-5Modified Release dosage forms: Matrix and multi-unit systemsModified Release dosage forms: Osmotic and enteric systemsKnow about formulation components of different dosage forms we studied & important excipient (polymer) examples responsible for controlling the release in each typeKnow difference between delayed release & modified releaseKnow about differences between single unit and multiunit dosage formKnow about pH range & residence time in different parts of GIT Know advantages & disadvantages of each type of MR dosage form we studiedBe able to identify type of MR dosage form / release mechanism based on inactive ingredients list / name of excipient from marketed productKnow about important patient counseling points related to specific dosage form 8-11Solutions: factors affecting drug solubilityAdvantages & disadvantages of solutions, pharmacist’s role in solution dosage formKnow about the drug solubility and factors affecting solubilityUnderstand the approaches to improve solubilityKnow about different additives in solutions, syrups & elixirs;Understand the role of each additive and few important examples of each additive used in solutions3-5Solutions, syrups and elixirsKnow about components of solutions, syrups & elixirs and important examples of each component.Know about methods of preparation of solutions, syrups & elixirsKnow about characteristics & differences between syrups & elixirs.Know about storage and handling of solution, syrups, elixirs3-5Sample questions:The effectiveness of a drug is assessed in human (patients) for first time during-------- clinical trials.Phase 1Phase 2Phase 3 Phase 1 and 2Which one of the following is NOT a physical property of drug substance being evaluated during preformulation studies? Particle size distributionDegradation profileSolubilityPolymorphismCrystalline or amorphous natureExcipients are added to tablet dosage form to improve processability. An ideal excipient should have all these properties EXCEPT Non-toxicPhysiologically activeStableLow costPitt School of Pharmacy is developing an immediate release tablet dosage form for a new chemical entity “Pharmacy-123” for the treatment of acute pain. Pharmacy 123 is highly insoluble in water (BCS class 2) and its proposed dose is 10 mg every 4 h. If you are asked to design an immediate release tablets for Pharmacy 123, which excipient combination from following choices you will propose?Lactose, colloidal silicon dioxide, Magnesium stearateLactose, Polysorbate 20, colloidal silicon dioxide, croscarmalose sodiumLactose, Polysorbate 20, croscarmalose sodium, colloidal silicon dioxide, Magnesium stearateLactose, Polysorbate 20, colloidal silicon dioxide, Magnesium stearateGenerally, what is the upper limit of alcohol content in elixirs?30%40%50%60%70%Modified release dosage forms have all of the following advantages EXCEPTThey decrease the dosing frequency of the drugThey can decrease the total required dosage of drug in some casesThey increase difference between peak and trough plasma levels of the drug They provide uniform drug deliveryThey decrease side effects of drugs A water insoluble solid compound with a melting point of 62C needs to be formulated as a solid dosage form. The absorption of this compound from the gastrointestinal tract is highly dependent on the disintegration time of the dosage form (absorption rate increases with reduction in disintegration time). Which one of the following dosage forms will provide fastest disintegration time? Hard gelatin capsulesSoft gelatin capsulesDelayed release tabletsOsmotic pumpSustained release tabletsEither a or bAnswers to the sample questions are on next page.Answers to the questions:Phase 2Degradation profilePhysiologically active(C) Lactose (filler), Polysorbate 20 (solubilizing agent), croscarmalose sodium (disintegrating agent), colloidal silicon dioxide (glidant), Magnesium stearate (lubricant)40%They increase difference between peak and trough plasma levels of the drugHard gelatin capsules ................
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