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Compounding Test 1
Discussion 2 (Dosage Formulations)
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Professional
01/21/2013

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Term

Dosage Forms

NAPLEX/USP

(7)

Definition
  • These items are routinely test on the NAPLEX (board) exam
    • www.uspnf.com
    • utah2000 opah4carl
  • USP General Chapters
    • <1151> Pharmaceutical Dosage Forms 
    • <1176> Prescription balance and volumetrics 
    • <1251> Weighing on an analytical balance 
Term

Dosage Forms

The need for dosage forms

(12)

Definition
  • Dosage forms are the pharmaceutical mechanisms and technologies by which Active Pharmaceutical Ingredients (API) are delivered to sites of action within the body
  • The need for dosage forms:
    • Accurate dose
    • Protection e.g. coated tablets, sealed ampules
    • Protection from gastric juice
    • Masking taste and odor
    • Placement of drugs within body tissues
    • Sustained release medication
    • Controlled release medication
    • Optimal drug action
    • Insertion of drugs into body cavities (rectal, vaginal, urethral) 
    • Use of desired vehicle for insoluble drugs 
Term

Dosage Forms

Types of Dosage Forms

(3)

Definition
  • Forms may be classified by
    • Route of administration
    • Physical form
Term

Dosage Forms

Types of Dosage Forms

Route of Administration

(8)

Definition
  • Oral
  • Topical
  • Rectal 
  • Parenteral 
  • Vaginal / Urethral 
  • Inhaled 
  • Ophthalmic
  • Otic 
Term

Dosage Forms

Types of Dosage Forms

Physical Form

(4)

Definition
  • Solid
  • Semisolid
  • Liquid
  • Gas
Term

Dosage Forms

Common Formulations Include

(9)

Definition
  • Gases
    • medical gases, aerodispersions (aerosols)
  • Solid
    • powders, tabs, caps, lozenges (troche), transdermal patches, implants, medication sticks
  • Semi-solid
    • Unshaped gel, cream, ointment, emulsion, paste
    • Shaped suppositories, pessaries
  • Liquid
    • Solution, emulsion, suspension 
Term

Dosage Forms

Common Formulations Include

Gases

(2)

Definition
  • medical gases, 
  • aerodispersions (aerosols)
Term

Dosage Forms

Common Formulations Include

Solid

(7)

Definition
  • powders, 
  • tabs, 
  • caps, 
  • lozenges (troche),
  •  transdermal patches,
  •  implants, 
  • medication sticks
Term

Dosage Forms

Common Formulations Include

Semi-solid

(9)

Definition
  • Unshaped 
    • gel, 
    • cream, 
    • ointment, 
    • emulsion, 
    • paste
  • Shaped 
    • suppositories, 
    • pessaries
Term

Dosage Forms

Common Formulations Include

Liquid

(3)

Definition
  • Solution, 
  • emulsion, 
  • suspension 
Term

Dosage Forms

Dosage Form Components

(12)

Definition
  • Active Pharmaceutical Ingredient (API)
  • Pharmaceutical Excipient
    • binders
    • coatings
    • disintegrants
    • fillers / diluents
    • flavors / scents / colors lubricants / glidants
    • preservatives
    • surfactants
    • humectants
    • propellants
  • Container 

 

Term

Dosage Forms

Aerosols
Package and Route
(8)
Definition
  • Packaged under pressure and contain API released upon valve activation
  • Routes
    • Skin application (dermal aerosol) – 
    • Local application
      • Nose (nasal aerosol)
      • Mouth (oral aerosol)
    • Lungs (inhalation aerosol)
  • Valve may allow metered or continuous dose delivery 

 

Term

Dosage Forms

Aerosols
Components
(5)
Definition
  • Container
  • Propellant
  • Concentrate (containing API +/- excipients)
  • Valve
  • Actuator 
Term

Dosage Forms

Aerosols
Particle Size
(2)
Definition
  • Particle size ranges from < 5 μm to 100+ μm
    • MDI for inhalation particle size must be < 5 μm 
Term

Dosage Forms

Capsules

Solid Dosage Forms

(9)

Definition
  • Drug enclosed in either hard or soft soluble container or shell
    • Shells usually formed from gelatin
    • Can also be starch or other substances 
  • Hard shell size range
    • No. 5 (smallest) to No. 000 (largest)
      • Usually, No. 00 is largest tolerated by humans
  • Two parts: Cap and Body
    • Multiple methodologies for closure – 
    • Grooves, banding, heat, chemical 
Term

Dosage Forms

Capsules

Delayed Release

(4)

Definition
  • Intended merely to allow contents to pass through stomach
  • Many types of methods
    • Coating of outer surface of capsule
    • Beads with different dissolution rates 
Term

Dosage Forms

Capsules

Extended Release

(2)

 
Definition
  • Sustained-release, controlled-release
  • Other dissolution technologies involved to prolong drug action over hours-days-months 
Term

Dosage Forms

Creams

(7)

Definition
  • Semi-solid dosage forms
  • One or more API dissolved in suitable base 
  • Typically highly fluid (low viscosity)
    • Oil-in-water emulsion
    • Aqueous dispersions
    • Water-washable bases / “vanishing” creams
  • Usual dosage form for vaginal drug delivery 
Term

Dosage Forms

Ointments

(7)

Definition
  • Semisolid preparation
  • Intended for external application to skin
  • Typically four types of ointment bases
    • Hydrocarbon bases
    • Absorption bases
    • Water-removable bases 
    • Water-soluble bases 
Term

Dosage Forms

Emulsions
(9)
Definition
  • Two-Phase Systems
    • One liquid dispersed into another liquid using small droplets
      • Internal Phase - droplets, discontinuous phase
      • External phase - Continuous Phase
    • Stabilized by the addition of one or more emulsifying agents
      • Prevent Coalescence
      • Surfactants
    • Oil-in-water (O/W)
    • Water-in-oil (W/O)
Term

Dosage Forms

Extracts

(2)

Definition
  • Concentrated preparations of vegetable or animal drugs obtained by removal of active ingredients by evaporation of solvent
    • Use of percolation, and concentration by distillation under pressure 
Term

Dosage Forms

Fluidextracts

(2)

 
Definition
  • Liquid preparations of vegetable drugs, containing alcohol as a solvent
    • 100% extract (1 mL of product contains 1 g API) 
Term

Dosage Forms

Gels

(9)

Definition
  • Semisolid systems 
    • consisting of either
      • suspensions made up of small inorganic particles
      • large organic molecules interpenetrated by a liquid
    • May be single phase or two-phase systems 
    • Often thixotropic
      • form semi-solid upon standing
      • form fluid upon agitation
    • Usually only for topical or local administration 
Term

Dosage Forms

Inhalations

(5)

Definition
  • May be solution, suspension, dry powder
  • Usually require some mechanical device to delivery
    • MDI
    • Dry Powder inhaler
    • Nebulizer 
Term

Dosage Forms

Opthalmic Preperations

(11)

Definition
  • All preparations have to be sterilized – 
  • Ointments
    • API added to base as either solution or powder • 
    • Container must be sterilized prior to formulation • 
    • Formulation must be sealed and tamper-”proof”
  • Solutions
    • Must be adjusted for isotonicity
    • Commonly used membrane filtration under aseptic conditions to sterilize – 
  • Suspensions
    • Solid particles in liquid preparation • 
    • Micronized form 
Term

Dosage Forms

Solutions

(13)

Definition
  • One-phase systems
  • API/excipients completely dissolved in liquid solvent
  • May be; 
    • oral, 
    • topical, 
    • otic,
    •  ophthalmic, 
    • parenteral
  • Also includes 
    • Spirits
      • Alcoholic or hydroalcoholic solutions of volatile substances
    • Tinctures
      • Concentrated “spirits” – typically much more potent 

 

Term

Dosage Forms

Suspensions

(8)

Definition
  • Two-phase systems
    • Solid dispersed into liquid
    • May be;
      • oral,
      • topical, 
      • otic, 
      • ophthalmic,
    • parenteral (NOT IV) 
Term

Dosage Forms

Suppositories

(5)

Definition
  • Solid bodies of various weights and shapes
    • Intended for rectal, vaginal, or urethral administration
    • Usually melt, soften, or dissolve at body temperature
    • May be used for direct application of API, or may be used in protective or palliative purpose at tissue site
    • Selection of base material is important to drug delivery 
Term

Dosage Forms

Tablets

(6)

Definition
  • The most common dosage form 
  • Solid dosage forms
    • Classified based on methods of manufacture 
      • Compressed or molded tablets
    • Chewable tablets
    • Coatings often impart Delayed release or extended release characteristics 
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