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
Functional Excepients
Purposes
Release Rate
pH
coating/matrix protects drug from acid degradation
Flavor
blocks the bitterness
Manufacturing
powders etc that need to be able to survive the manufacturing process
Preservative
keep the drug good for a while
NON-Functional Excipients
& purposes
COLOR / APPEARANCE
so ppl will take it = complience
What dosage forms are possible for a
drug destroyed in ACID?
Avoiding Acid
Enteric Coated Tabs
Sublingual tab (low dose)
Buccal Tablet (low dose)
Injection
Rectal Suppository
What is the MOST DIFFICULT dosage form to formulate?
GRANULES FOR RECONSTITUTION
Drug / Color / Flavor
only last 2-3 weeks after reconstitution
needs to also be
Able to Re-suspend in those 2-3 weeks
