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level: Level 1 of DOSAGE FORM DESIGN CH4 Part 2

Questions and Answers List

level questions: Level 1 of DOSAGE FORM DESIGN CH4 Part 2

QuestionAnswer
- study on the: formulation, manufacture, stability, and effectiveness of pharmaceutical dosage formsPharmaceutics
Requirements of a proper design & formulation of dosage form1 Physical, chemical & biological characteristics 2 Compatible with one another - stable, efficacious, attractive, easy to administer & safe 3 Manufactured under appropriate measures of quality control & packaged in containers to make product stable 4 Labeled to promote correct use & stored under conditions to maximize shell life
Pharmaceutical ingredients or excipients uses1 solubilize 2 thicken 3 stabilize 4 flavor 5 suspend 6 dilute 7 preserve 8 efficacious 9 emulsify 10 color appealing 11 closure forms.
General Considerations in Dosage Form Design1 Determine desired product type 2 Initial formulations of the product 3 Master formula
framework for product development.Determine desired product type
desired features: drug release profile, bioavailability, clinical effectiveness pilot plant studies and production scale-up.Initial formulations of the product
- formulation that best meets the goals of the productMaster formula
Factors to consider before formulation of a medicinal agent in one or more dosage forms1 Therapeutic matters (nature of the illness) 2 Manner it is treated (locally or through systemic action) 3 Age and anticipated condition of the patient.
drug be chemically and physically characterized provide the type of information needed to define the nature of the drug substance.Preformulation Studies
Preformulation Studies1 Physical Description 2 Microscopic Examination 3 Heat of Vaporization 4 Melting Point Depression 5 Phase Rule 6 Particle Size 7 Polymorphism 8 Solubility 9 Dissolution 10 Membrane Permeability 11 Partition Coefficient 12 pKa / Dissociation Constants 13 Hydrates and Solvates 14 Organic Salt Considerations 15 Organic Ester Consideration
extent a product retains within specified limits and through its period of storage and useStability
Stability studies conducted in the preformulation phase:1 Solid-state of the drug alone 2 Solution phase with the expected excipients
1 Most frequently encountered destructive process 2 these are susceptible to the hydrolytic process:1 Hydrolysis (solvolysis process), and Oxidation 2 esters, substituted amides, lactones, and lactams
Drug and Drug Product Stability:A. Kinetics and Shelf Life B. Rate Reactions C. Q10 Methods
Five types of stability1 Chemical - retains chemical integrity 2 Physical - original physical properties 3 Microbiologic - resistance to microbial growth 4 Therapeutic - therapeutic effect unchanged 5 Toxicologic - no toxicity occurs
-description of the drug concentration with respect to time.RATE REACTIONS
estimate the shelf life of a product that has been stored or to be stored under a different set of conditions.Q10 METHOD