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2. Give the principal reason for the need of dosage forms and some dosage forms for specific reasons.
To protect the drug substance from the destructive influences of atmospheric oxygen or humidity. (Coated tablets) To protect the drug substance from the destructive influence of gastric acid after oral administration. (Enteric-coated) To conceal the bitter, salty or offensive taste or odor of a drug substance. (Capsules, Flavored syrups) To conceal the bitter, salty or offensive taste or odor of a drug substance. (Capsules, Flavored syrups) To provide clear liquid dosage forms of substances. (Syrups, Solutions) To provide rate-controlled drug action. (Controlled-release tablets) To provide optimal drug action from topical administration sites. (Ointments,Creams, Transdermal patches) To provide for insertion of a drug into one of the bodys orifices (Suppositories) To provide placement of drugs directly in the bloodstream or body tissues (Injections)
To provide for optimal drug action through inhalation therapy (Inhalants, Inhalation aerosols)
3. Before medicinal substance is formulated, what factors related to illness must be considered?
Following are the factors that must be considered before medicinal substance is formulated: Therapeutic matters (nature of the illness) Manner it is treated (locally or through systemic action) Age and anticipated condition of the patient.
4. Give 3 ways by which a liquid drug could be given in solid form to be given orally.
Liquid substance: Sealed in soft gelatine capsule Developed into a solid ester or salt form suitable for tablets or drug capsules Mixed with a solid or melted semisolid material melted mixture is poured into hard gelatine capsules to harden & capsules sealed
d.) Rate reaction It is the description of the drug concentration with respect to time. e.) Extent of dissociation/ionization It is the extent of ionization of drug - strong effect on formulation & pharmacokinetic parameters of the drug. It is determined by potentiometric titration. f.) Ficks Law (Law of Diffusion) It describes the relationship of diffusion & dissolution of the active drug in the dosage form & when administered in the body. - 1st law Relates to a steady state flow - 2nd law Relates to a change in conc. of drug with time, at any distance, or a nonsteady state of flow
d.) Molecules lipophilic character It is measured by the oil-water coefficient. e.) pKa It is determined by potentiometric titration. For the pharmacists, it is important to predict the precipitation in admixtures and to calculate the solubility of drugs at certain pH values. f.) Shelf-life determination It has to be estimated based on assay results of the drug characteristic from a stability study usually conducted during the process of drug development. 7. How will these factors affect solubility of the drugs substance? (NOT SURE OF THE ANSWER) If a drug is formulated to liquid product, adjustment of pH of solvent where drug is dissolved to adjust solubility. Further, chemical analysis of the drug content in solution is performed to determine degree of solubility. 8. Give ways by which dissolution rate is increased. a.) The dissolution rate of drugs may be increased by decreasing the drugs particle size. b.) It may also be increased by increasing its solubility in diffusion layer. c.) The most effective means of obtaining higher dissolution rates is to use a highly water soluble salt of the parent substance.
10. What are the 5 processes by which a drug could be degraded? a.) Polymerization It is a reaction between two or more identical molecules with resultant formation of new & generally larger molecule (Ex. formaldehyde) b.) Decarboxylation The decomposition of Carboxylic acid (R-COOH) and release of carbon dioxide (CO2) c.) Deamination The removal of nitrogen containing group from organic amine (Ex. Insulin) d.) Hydrolysis The process in which drug molecule interact with water molecules to yield breakdown products of different chemical constitution. (Ex. Aspirin) e.) Oxidation A destructive process occurring in pharmaceutical. Chemically, it involved the change in the number of electrons from an atom or molecule.
13. Differentiate long term stability studies with accelerated stability studies according to:
Long term stability studies Product is subjected to different climatic zones (temperature & humidity) nationally and internationally Accelerated stability studies Use of exaggerated conditions of temperature, humidity, light and others
Duration Temperature
12 months minimum Conducted at 25 o C +/- 2oC and at a relative humidity of 60% +/- 5%
6 months study 40 o C
Humidity
14. What are the FDA guidelines on stability for extemporaneous compounding?
Nonaqueous liquids & solid formulations (Source of active ingredient)s Not later than 25% of the time remaining until the products expiration date or 6 months, whichever is earlier Nonaqueous liquids & solid formulations in w/c USP or NF substance (Source of ing) Beyond-use not later than 14 days in storage at cold temperatures Other formulations beyond-use date of the intended duration of therapy or 30 days whichever is earlier
15. Tabulate some pharmaceutic ingredients, their uses and common examples.
Uses Used to dissolve the drug substance Used to make the product more palatable Added to enhance appeal May be added to prevent microbial growth
17. Give examples of sweetening agents and their advantages and disadvantages. Sweetening Agents Advantages helpful aid in weight loss due to the fact that it contains no sugar, no calories and has been shown to reduce craving for sweets and fatty foods. Disadvantages it leaves some unpleasant tastes such as a bitter taste. In other words, it is undesirable for a sweetening to contain large amounts of Stevioside. may cause sulfa allergies and has possible carcinogenic properties when consumed in very large amounts the use of aspartame by persons with phenylketonuria (PKU) is discourages,
Saccharin
Aspartame
breaks down in the body into three basic components: the amino acids phenylalanine and
and diet foods and drinks must bear appropriate label warning
18.
The synthetic coloring agent comes mostly from coal tar (pix carbonis) black, viscid liquid which is a byproduct in the destructive distillation of coal. Most pharmaceutical colorants are synthetic origin; few are naturally occurring principles obtained from mineral, plants and animal source
Solubility of the dye should be the first to be studied in the solvent or vehicle used. Dyes may be grouped into water soluble or oil soluble. pH Dyes can change color with a change of pH. The color must be chemically stable in the environment of the other formulative ingredients for the shelf life; dye must be photostable.
c) Irreversible coagulation of cytoplasmic constituents; d) Inhibition of cellular metabolism by interfering with enzyme systems/inhibition of cell wall synthesis; e) Oxidation of cellular constituents; and f) Hydrolysis