Term
Dosage Forms
NAPLEX/USP
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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
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Term
Dosage Forms
The need for dosage forms
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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
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Term
Dosage Forms
Types of Dosage Forms
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Definition
- Forms may be classified by
- Route of administration
- Physical form
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Term
Dosage Forms
Types of Dosage Forms
Route of Administration
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Definition
- Oral
- Topical
- Rectal
- Parenteral
- Vaginal / Urethral
- Inhaled
- Ophthalmic
- Otic
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Term
Dosage Forms
Types of Dosage Forms
Physical Form
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Definition
- Solid
- Semisolid
- Liquid
- Gas
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Term
Dosage Forms
Common Formulations Include
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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
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Term
Dosage Forms
Common Formulations Include
Gases
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Definition
- medical gases,
- aerodispersions (aerosols)
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Term
Dosage Forms
Common Formulations Include
Solid
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Definition
- powders,
- tabs,
- caps,
- lozenges (troche),
- transdermal patches,
- implants,
- medication sticks
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Term
Dosage Forms
Common Formulations Include
Semi-solid
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Definition
- Unshaped
- gel,
- cream,
- ointment,
- emulsion,
- paste
- Shaped
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Term
Dosage Forms
Common Formulations Include
Liquid
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Definition
- Solution,
- emulsion,
- suspension
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Term
Dosage Forms
Dosage Form Components
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Definition
- Active Pharmaceutical Ingredient (API)
- Pharmaceutical Excipient
- – binders
- – coatings
- – disintegrants
- – fillers / diluents
- – flavors / scents / colors – lubricants / glidants
- – preservatives
- – surfactants
- – humectants
- – propellants
- Container
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Term
Dosage Forms
Aerosols
Package and Route
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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
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Term
Dosage Forms
Aerosols
Components
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Definition
- Container
- Propellant
- Concentrate (containing API +/- excipients)
- Valve
- Actuator
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Term
Dosage Forms
Aerosols
Particle Size
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Definition
- Particle size ranges from < 5 μm to 100+ μm
- MDI for inhalation – particle size must be < 5 μm
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Term
Dosage Forms
Capsules
Solid Dosage Forms
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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
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Term
Dosage Forms
Capsules
Delayed Release
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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
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Term
Dosage Forms
Capsules
Extended Release
(2)
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Definition
- Sustained-release, controlled-release
- Other dissolution technologies involved to prolong drug action over hours-days-months
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Term
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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
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Term
Dosage Forms
Ointments
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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
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Term
Dosage Forms
Emulsions
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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)
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Term
Dosage Forms
Extracts
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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
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Term
Dosage Forms
Fluidextracts
(2)
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Definition
- Liquid preparations of vegetable drugs, containing alcohol as a solvent
- 100% extract (1 mL of product contains 1 g API)
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Term
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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
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Term
Dosage Forms
Inhalations
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Definition
- May be solution, suspension, dry powder
- Usually require some mechanical device to delivery
- MDI
- Dry Powder inhaler
- Nebulizer
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Term
Dosage Forms
Opthalmic Preperations
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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
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Term
Dosage Forms
Solutions
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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
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Term
Dosage Forms
Suspensions
(8) |
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Definition
- Two-phase systems
- Solid dispersed into liquid
- May be;
- oral,
- topical,
- otic,
- ophthalmic,
- parenteral (NOT IV)
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Term
Dosage Forms
Suppositories
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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
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Term
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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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