DosageFormDesignPharmaceuticalandFormulation.ppt

3. Dosage Form Design: Pharmaceutic and Formulation Considerations Contents The need for dosage forms General considerations in dosage form design Drug and drug product stability Pharmaceutical ingredients The pharmaceutic ingredients solubilize, suspend, thicken dilute emulsify stabilize preserve color flavor The general area of study concerned with the formulation manufacture stability effectiveness of pharmaceutical dosage forms. A drug product stable efficacious attractive easy to administer safe manufactured under appropriate measures of quality control 1. The need for dosage forms Besides providing the mechanism for the safe and convenient delivery of accurate dosage, dosage forms are needed for additional reasons: 1) Protection from oxygen and humidity (coated tablets, sealed ampuls) 2) Protection from gastric acid after oral administration (enteric-coated tablets) 3) To conceal the bitter, salty, or offensive taste or odor of a drug substance (capsules, coated tablets, flavored syrups) 4) 5) 6) To provide rate-controlled drug action (various controlled-release tablets, capsules and suspensions) 7) To provide topical drug action from topical administration sites (ointments, creams, transdermal patches, ophthalmic, ear, and nasal preparations) 8) To provide for the insertion of a drug into one of the body’s orifices (e.g., rectal or vaginal suppositories) 9) To provide for the placement of drugs directly into the bloodstream or into body’s tissues (e.g., injections) 10) To provide for topical drug action through inhalation therapy (e.g., inhalants and inhalation aerosols) 2. General considerations in dosage form design Desired features Drug release profile Bioavailability Clinical effectiveness Factors considered the nature of illness the manner in which it is treated age anticipated condition of the patient Because they plays a role in dosage form design Preformulation studies Before the formulation of a drug substance into a dosage form,