8 - Solid Products Flashcards
Components of the DOSAGE FORM
Preformulation Considerations
Both sterile & non-sterile
Preformulation Studies are ALSO conducted on
CRITICAL INACTIVE INGREDIENTS
Active Drug
aka = Bulk Drug / Active / Active pharmaceutical ingredient = API
EXCIPIENTS
inactive ingredients includes gelatin capsule
dosage form / manufacturing support
PACKAGING
maintain drug product STABILITY
bottle / cap / seal / film / foil / glue
Administration Device
oral syringe / cup / food /etc
Objectives of Preformulation Studies
Preformulation Studies are ALSO conducted on
CRITICAL INACTIVE INGREDIENTS
Patient Consideration = Bioavailability
physiology / dissolution -> clnical Effect
Technical Chemistry
Stability / properties of API & dosage form / Dissolution profile
Compliance
size of dose (XR) / color / taste / etc so patients WILL TAKE IT
Business / Marketing
What type of Dosage form is this?
Admin: Swallow
Design: FAST dissolution
Special: must NOT dissolve/disintegrate in mouth
Dissolution Profile - BV curve
UNCOATED TABLETS
Generic Asprin / APAP
What type of Dosage form is this?
Admin: Swallow
Design: Fast Disintegrate
Special: must NOT disintegrate in MOUTH nor in COATING PROCESS
Dissolution Profile: BV Curve
NON-FUNCTIONAL COATING
COATED TABLET
Vitamins
What type of Dosage form is this?
Admin: Swallow
Design: NO Dissolution in Acid PH, FAST DISSOLUTIOn in alkaline pH
Special: Functional Excipient = Enteric Coating
Dissolution Profile: BV curve
ACID-Protection FUNCTIONAL COATING
Coated Tablet
Ery-Tab Delay release tablets
What type of Dosage form is this?
Admin: swallow
Design: Controlled Release Dissolution
Special: Functional Excipient / Hydroxypropyl cellulose in tablet CORE
Dissolution Profile: BV Curve
Functional Coating - CONTROLLED RELEASE
Coated Tablets
Depakote ER Tablets
What type of Dosage form is this?
Admin: Chew b4 swallowing
Design: Taste / Feel / hardness
Special: Functional Excipients - Mannitol (soft)
Dissolution Profile: crushed vs whole
BV Curve: chewed vs whole
CHEWABLE TABLETS
Tylenol Chewable
What type of Dosage form is this?
Admin: Chew b4 swallowing
Design: Taste / Mouth feel
Special: Functional Excipients - GELATIN base
Dissolution Profile: crushed vs whole
BV curve: Chewd vs swallowed
SOFT CHEWABLE TABLETS
Vitamin Gummies
What type of Dosage form is this?
Admin: Dissolve in liquid
Design: Acid-Base Rxn when wet + flavor/color
Special: Functional Excipients - Citric Acid + Sodium Carbonate
Low humidity for anufacturing, foil pouch package
Dissolution Profile:
EFFERVESCENT TABLETS
Alka-Sletzer
What type of Dosage form is this?
Admin: Dissolve under tongue, DO NOT SWALLOW
Design: Soluble Excipients
Special: Soluble excipients must dissolve in mouth
small/fragile tablets
Dissolution Profile:
SUBLINGUAL TABLETS
Nitroglycerin Tabs
What type of Dosage form is this?
Admin: let dissolve in buccal cavity over 10-15 min
Design: Slow dissolution + Flavor (no disintegrate)
Special: TASTE
BV curve: buccal vs swallowed
BUCCAL TABLETS
Testosterone Tablets
What type of Dosage form is this?
Admin: Dissolve in mouth
Design: Good Taste / Mouth Feel
Special: FAST dissolution, soluble excipients
Dissolution Profile:
ORAL DISINTEGRATING TABLETS
Claritin
What type of Dosage form is this?
Admin: Swallow
Design: Extended release of API
Special: Slow Release excipients
Dissolution Profile: prolonged dissolution (hours)
BV profile = prolonged
EXTENDED RELEASE TABLETS
aka MODIFIED RELEASE
MULTIPLE designs possible
Potassium Chloride XR Tabs
What type of Dosage form is this?
Admin: Swallow
Design: FAST DISSOLUTION
Special:
Dissolution Profile:
- *HARD GELATIN CAPSULE**
- *SOLID FILL = Benadryl Capsule**
- *Liquid Fill = Gengraf Capsule**
- *Soft Gelatin Capsule**
- *Liquid Fill, Solution or Suspension = Norvir / Accutane**
PAINTBALLS!
Unique Characteristic of Gummy/Troche
GELATIN
