| - study on the: formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms | Pharmaceutics |
| Requirements of a proper design &
formulation of dosage form | 1 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 uses | 1 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
Design | 1 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
product | Master formula |
| Factors to consider before formulation of a
medicinal agent in one or more dosage
forms | 1 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 Studies | 1 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 use | Stability |
| 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 stability | 1 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 |
