Dosage Forms Flashcards by Mark Agustin

composed of a solid or mixture of solids reduced to a FINELY DIVIDED and intended for internal or external use

Powder

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composed of DRY AGGREGATES of powder particles that may contain one or more APIs, with or without other ingredients

Granules

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solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small SHELL OF GELATIN

Capsules

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solid dosage forms usually prepared with the aid of suitable pharmaceutical EXCIPIENTS -> COMPRESSED

Tablet

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semisolid preparations intended for external application to the SKIN or MUCOUS membrane

Ointment

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are solid dosage forms intended for insertion into body ORIFICES where they melt, soften, or dissolve and exert local or systemic effects

Suppositories

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liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of NATURALLY MISCIBLE solvents

Solutions

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preparations containing finely divided drug particles (the SUSPENSOIDS) distributed somewhat uniformly throughout a vehicle in which the drug exhibits a MINIMUM degree of solubility

Suspensions

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*dispersion in which the dispersed phase is composed of small globules of a LIQUID distributed throughout a VEHICLE in which it is IMMISCIBLE

*Select the oral dosage form, which contains one or more active ingredients that are unstable in the water phase but stabilized in oil-in-water dispersions; either or both phases may contain

Emulsions

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PRESSURIZED dosage forms that, upon actuation, emit a fine dispersion of LIQUID and/or SOLID materials containing one or more active ingredients in a GASEOUS medium

Aerosols

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use repetitive, INTERMITTENT dosing of a drug from one or more immediate-release units incorporated into a single dosage form
Do not produce or maintain uniform drug blood levels within the therapeutic range
e.g., enteric-coated tablets, repeat-action tablet, prolonged action

Delayed-release systems

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*achieves SLOW release of drug over an extended period of time
*non-constant
*First Order Kinetics

Sustained-release systems ***

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*maintains therapeutic blood levels of
the drug for a PROLONGED period

Extended-release

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*release at nearly CONSTANT RATE
*Zero Order

Controlled Release

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delivery of a drug at a PREDETERMINED rate and/or location according to the needs of the body

Controlled Drug Delivery

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targeting the diseased organ or tissue (or the adjacent parts)

Site-specific targeting

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target: receptor within organ or tissue

Receptor targeting

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pharmaceutical dispersed system that is a LOW VISCOSITY LIQUID preparation intended for application to the skin.

Lotion

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8 (NMT 20% pass thru no. 60)

OFFICIAL DEFINITION OF POWDERS OF
ANIMAL AND VEGETABLE DRUGS

Very Coarse

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20 (NMT 40% pass thru no. 60)

OFFICIAL DEFINITION OF POWDERS OF
ANIMAL AND VEGETABLE DRUGS

Chemical 20

Coarse

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40 (NMT 40% pass thru no. 80)

OFFICIAL DEFINITION OF POWDERS OF
ANIMAL AND VEGETABLE DRUGS

Chemical 40

Moderately Coarse

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60 (NMT 40% pass thru no. 100)

OFFICIAL DEFINITION OF POWDERS OF
ANIMAL AND VEGETABLE DRUGS

Chemical 80

Fine***

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OFFICIAL DEFINITION OF POWDERS OF
ANIMAL AND VEGETABLE DRUGS

Sieve No. 80
No limit
Chemical 120

Very Fine***

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For NON-potent drugs
NON-individual dosing
Packaging - bottles (wide open), aerosols, sifter cans

Bulk Powder

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What are the type of Bulk Powder (5)

1. Dentrifices 2. Oral powder 3. Douches 4. Insufflation 5. Dusting Powder

* powder for cleaning TEETH * Abrasive, anti-CARIOGENIC

Dentrifices

Intended to be SWALLOWED (dissolved in water prior to use)

Oral powder

* cleanse the VAGINA * dispensed in the forms of tablets or powder * powder is dissolved in warm (tepid) water * pH usually 3.5 to 5 when the solution is prepared

Douches

* introduced into BODY CAVITY * powder is placed in insufflator →squeeze the bulb to release particles trough the nozzle to the region for which the medication is intended. * passed through a mesh # 100

Insufflation

* dusted on the skin by means of sifter-top containers * provides NO systemic toxicity * grit-free --> impalpable to touch

Dusting Powder

◼ Aka Chartula/Chartulae ◼ For POTENT drugs ◼ Powders divided into single doses ◼ Packaging: Individualized more accurate dosage form than bulk powder

DIVIDED POWDERS

TYPES OF PAPER USED FOR DIVIDED POWDERS *transparent WAXY paper *HIGHEST MOISTURE RESISTANT for drugs that are volatile, hygroscopic, deliquescent, efflorescent

Waxed Paper

TYPES OF PAPER USED FOR DIVIDED POWDERS *LIMITED MOISTURE RESISTANCE *also for volatile substances *GLAZED transparent paper

Glassine Paper

TYPES OF PAPER USED FOR DIVIDED POWDERS *LIMITED MOISTURE RESISTANCE *thin, semi-opaque paper

Vegetable Parchment

TYPES OF PAPER USED FOR DIVIDED POWDERS *NO MOISTURE RESISTANCE *for non-volatile, or ingredients not adversely affected by air or moisture

Bond Paper

◼ powder + small amount of liquid FORMING A PASTE ◼ use of NON--volatile, NON-solvent known as LEVIGATING AGENT ◼ examples 1. Mineral oil (BEQ: aka liquid paraffin) 2. Castor oil 3. PEG

Levigation

◼ grinding using MORTAR & PESTLE 1. Glass Mortar 2. Porcelain/Wedgewood ◼intended both to MIX and COMMINUTE

Trituration ***

◼ use of VOLATILE solvent such as ALCOHOL (camphor reduction), ETHER (iodine reduction) ◼ applicable for GUMMY materials

Pulverization by Intervention

Mechanical method of particle size reduction

Milling

*Principle: CUTTING *For comminuting 1. fibrous 2. crude drugs Shear cutting cutting (in chikading song)

Shear Mill

*Principle: compression w/ application pressure

End Runner Mill

*Principle: Impact *Comminuting ALMOST ALL drugs, except thermoLABILE substances

Hammer Mill

*Principle: Impact and attrition *Ball as grinding medium *Pin as impactor

Ball and Pin Mill

*Principle: attrition and compression

Rolling Mill

*Blending small amounts of powders by movement of SPATULA *Not for LARGE-scale or POTENT powders

Spatulation (or small scale, non-potent)

*Small amount of POTENT drug substances + large amount of DILUENT *to ensure the uniform distribution of potent drugs

Geometric Dilution

*Powder is enclosed in a LARGE container which rotates by a motorized process * For large-scale mixing

Tumbling

*Use of a SIFTER *Result: light, fluffy powder *Not for POTENT drugs

Sifting

*Agglomerates of powders *Requirement: 4-12 mesh sizes (or 0.2-4 mm)

Granules

Why granulate?

1. ↑ FLOW and compaction 2. ↑ COMPRESSIBILITY in tablet manufacturing process 3. ↓ DUST during material processing 4. UNIFORMLY distributes essential ingredients within the granules

*MOST WIDELY EMPLOYED method to produce compressed tablets *Equipment: Fluid Bed Granulator

Wet Granulation

For drugs that are DEGRADED BY MOISTURE or elevated temperature required for drying the wetted material

Dry Granulation

OVERWETTING to resulting granules

Granules will be HARD

UNDERWETTING to resulting granules

Granules will be SOFT, tend to CRUMBLE

What are the DILUENTS/FILLERS (bulking agent, size enhancer)

Lactose - most common diluent Mannitol Xylitol Starch Kaolin

What are the DISINTEGRANTS (promote ↑ break-up)

Starch Alginates Cellulose Clays Gums

What are the BINDERS (gluers or ↑ adhesion)

Natural: Gums Synthetic: Methylceullose, Ethylcellulose***

What are the GLIDANTS & LUBRICANTS (to improve flowability/flow activators)

Glidant example: colloidal silicon dioxide -Mg stearate -Ca stearate

Calamine is pink because of

Fe2O3

Use to disguise the bitter taste of Quinine

Yerba santa - Eriodictyon (best answer)

What is the BEST VEHICLE 1.Salty (e.g., Ammonium chloride) 2.Bitter (e.g., quinine) 3.Acrid or sour tasting (e.g., HCl) 4.Oily taste (e.g., castor oil)

BEST VEHICLE 1. Cinnamon Syrup 2. Cocoa (if not available, raspberry, cherry, cinnamon) 3. Raspberry 4. Aromatic rhubarb or sarsaparilla syrup

Flavoring Methodology ✓ Sour taste- FRUITY flavors, salty flavors ✓ Bitter – blended with salty, SWEET and sour tastes ✓ Chemicals used in blending: VANILLIN, MSG, benzaldehyde

Blending

Flavoring Methodology ✓ Addition of flavor whose intensity is longer and STRONGER than the obvious taste ✓ Methyl salicylate, Glycyrrhiza (Licorice), oleoresins

Overshadows

Flavoring Methodology ✓ Formation of INSOLUBLE compounds of the offending drug (e.g., SULFONAMIDE) ✓ EMULSIFICATION of oils, EFFERVESCENCE (magnesium citrate solution) ✓ High viscosity of fluids to LIMIT CONTACT OF DRUG with the TONGUE ✓ Mechanical procedures (COATING tablets)

Physical

Flavoring Methodology ✓ Absorption of the drug on a substrate or formation of COMPLEX of the drug with ion-exchange RESIN or complexing agents

Chemical

Flavoring Methodology ✓ Taste buds is ANESTHETIZED by MENTHOL or MINT flavors

Physiological

Methods of Coating Tablets (SUGAR-COATING TABLETS) 5 Steps

1. Waterproofing and Sealing 2. Subcoating 3. Smoothing and final rounding 4. Finishing (and coloring, if desired) 5. Polishing

Waterproofing substance

Shellac

How many subcoats of sugar-based syrups in Subcoating Step

3-5 subcoats

Subcoating substances:

sucrose solution (gelatin, acacia, or PVP)

In Step 3 of sugar-coating tablets, how many additional coatings of a thick syrup to complete the rounding?

5-10

Methods of Coating Tablets (SUGAR-COATING TABLETS) This step is performed in a clean pan

Step 4: Finishing (and coloring, if desired)

What is use in polishing step of coating tablets?

beeswax, carnauba wax

METHODS OF COATING TABLETS: (5) ***

1. Sealing (waterproofing) 2. Subcoating 3. Smoothing (Grossing) 4. Color coating 5. Polishing (Polisher)

places a THIN, skin-tight coating of a PLASTIC-like material over the compressed tablet, to produce coated tablets having essentially the SAME weight, shape, and size as the originally compressed tablet

Film-coating tablets

*intended to pass through the stomach intact to disintegrate and release their drug content for absorption along the small intestine *must resist the dissolution in the highly acid environment of the stomach

Enteric-coating tablets

Non-aqueous *Opaquants (?) and colorant *** (in hard gelatin capsule)

Opaquant (TiO2)

Steps in DRY Granulation (6)

1. Weigh formulation/Milling 2. Mixing 3. Pre-compression/Slugging 4. Sieving/Sieve slugs 5. Final Mixing 6. Compression

Steps in WET Granulation (6)

1. Weigh & Mix Formulation 2. Prepare Damp Mass 3. Screening 4. Dry the wet granulation 5. Size granules by Dry Screening 6. Lubricate & Compress

◼ Most common method of preparation ◼ Use of tablet machine (TM) 1. Single Punch TM ✓ Simplest of all machine type

Compression

✓ More cost efficient ✓ Preferred by industries due to its high output.

Rotary Tablet Pressing Machine

PARTS OF A TABLET PRESS Controls SIZE and SHAPE

Die

PARTS OF A TABLET PRESS DIRECTS granules into the die ''Directs means direction pag nag tatravel need mo ng SHOE''

Feed shoe

PARTS OF A TABLET PRESS Controls HARDNESS ''Suntukin mo siya ng malakas''

Punch

PARTS OF A TABLET PRESS LOADS the granules HOLDS/STORES material for compression ''Hop in''

Hopper

PARTS OF A TABLET PRESS GUIDES punch movement ''tourGUIDE needs a track''

Cam track

Medicinal agents + inert substances + small shell of gelatin

Capsules

Parts of the Capsule 1. Shorter, wider 2. Taller, narrower

1. Cap 2. Body

What is the % of HGCs (hard gelatin capsules)

12-16% or 13-15%

a capsule composed of hard gelatin shell containing hundreds of tiny, coated beads/pellets of drugs for sustained release

Spansule

Method of capsule filling (small scale)

Punch Method

In Capsule Size *The higher the number =

the smaller the capsule size (small)

1. The LARGER size of capsule? 2. The SMALLER size of capsule?

1. 000 2. 5

MATERIALS FOR MAKING CAPSULES *partially hydrolyze COLLAGEN (connective tissues and bones of animals)

Gelatin

Weight in grams needed by a specified plunger to DEPRESS THE GEL (4mm) without breaking

Bloom Strength

*Encapsulate and hermetically SEAL LIQUIDS, suspensions, pasty materials, dry powders, and even pre-formed tablet *Composition = GELATIN + SUGAR + WATER + PLASTICIZER

Soft -Gelatin Capsule

SGC Process *more efficient *GEL RIBBON brought together -> Fill is injected -> Sealed (using pressure and heat)

Rotary or reciprocating die process

SGC Process *using series of molds; oldest method *Warm Gelatin sheet poured in MOLD -> Drug is placed -> Upper gelatin layer is added ->Capsule sealed by pressure

Plate process

*Dissolve or disintegrate slowly in the mouth *Dosage form of Strepsils

Lozenges

1.Molded lozenges = 2. Compressed lozenges =

1. Pastilles 2. TroChes

Sugar-based LOZENGE on STICK

Lollipop

Sometimes known as BEADS

PELLETS

Small, ROUND with active ingredient

Pills

◼ AW = volatile oil + water immiscible ◼ Used as perfumed vehicle ◼ Storage: light resistant container (amber)

Aromatic Water

◼ = Acacia + Water ◼ thick, viscid, adhesive liquids ◼ Use: Suspending Agent ◼ Category: Aqueous (colloid) sol'n, suspending agent

Mucilage

◼ Treatment of EAR infection ◼ Impacted cerumen removal

Otic Solution (ear solution)

◼ restores MOISTURE to dry nasal passages ◼ curbs INFLAMMATION of mucus membrane ◼ cleanse nasal passages ◼ nasal DECONGESTANT

Nasal Solution

◼ mouth cleanser ◼ treatment of oral mucus membrane diseases

Mouthwash

◼ sterile ◼ eye irrigating solution

Ophthalmic Solution

◼ Use: Contain antiseptic to treat oropharyngeal condition ◼ swish & spit

Gargle

◼ = Fruit extract + H2O ◼ Flavored vehicle with preservative

Fruit Juice

◼ Diluted acid = conc. acid + purified water (PW) ◼ Diluted HCl = treatment of achlorhydria ◼ Conc Expression 1. % w/w = concentrated acid 2. % w/v = diluted acid - typically: 10%w/v, except acetic acid: 6% w/v

Diluted Acids

◼ Aka Clysters ◼ Rectal injections ◼ Use: ✓ evacuation of bowel (laxative) ✓ retention enema (ulcerative colitis)

Enemas

◼ wash surgical wounds, incisions, and body tissues ◼ Requirements: ✓ sterile ✓ Passed Bacterial Endotoxin Test (BET) ✓ minimal amount of solid

Irrigation Solution

◼ Purified water + sucrose ◼ Methods of Preparation: 1. (+) heat 2. Agitation 3. Percolation

Syrup

◼Sucrose: 85g ◼SG = 1.313 ◼Self-preserving ✓ 65 %w/w ✓ 85 %w/v ◼Prepared by Percolation ◼low solvent capacity

Simple syrup, NF

*Clear, pleasantly flavored solution for oral use *Must contain alcohol (traditionally 5-40%) *Iso-alcoholic elixir = low-alcohol (8-10%) + high-alcohol (73-75%)

Elixirs ***

*Aka Essences * = Volatile oil + alcohol 1. HIGH Alcohol content: >60% 2. alcoholic or hydroalcoholic solution 3. medicinal agent 4. flavorant (orange spirit, cardamom) 5. Stored in light resistant container 6. Spirit + water = salting out

Spirits

Preparations obtained from vegetables & animal drugs

Extractives

1. (hydro)Alcohol + chemical (or soluble components of vegetable drugs) 2. Potency: 100mg/1mL = 10% 3. Alcohol content: 15-80% 4. Aging can cause precipitation of the inactive constituents (Mx: Glycerin) 5. Storage: light-resistant container

Tinctures

10% opium tincture (17-21% alcohol)

Laudanum

10% potency (74-80% alcohol)

Comp benzoin tincture

* Aka 100% Tincture * = Vegetable oil + alcohol + percolation * Potency: 1g/1mL = 100%

Fluidextract

*COLLOIDON = Pyroxylin + 1 alcohol + 3 ether *Flexible collodion = Collodion + 2% camphor +3% castor oil *Salicylic acid collodion = flexible collodion + 10% salicylic acid

Ethereal Solution ***

Aka Embrocation

LinimEnts

It contains Vitamin A & D

Oleovitamins

Ex: eugenol - dental analgesic

Toothache drops

TYPES OF COLLOIDS * Solvent-loving * High affinity b/w dispersed phased and dispersion medium (solvation) * NOT easily precipitated=thermodynamically stable

Lyophilic Lyo - solvent

TYPES OF COLLOIDS * Solvent-hating * Low solvation * EASILY precipitated=unstable

Lyophobic

*Surfactants *Micelles *** ✓ Aggregates of surfactants dissolved in a dispersion medium ✓ Aggregation occurs over a NARROW concentration range (50 or more monomers) ✓ Use: to INCREASE the solubility of materials that are normally INSOLUBLE (Phenomenon: Micellar Solubilization)

Association (Amphiphilic)

Concentration at which MICELLES ARE FORMED is termed as

Critical Micelle Formation

COLLOID PROPERTIES (under Kinetic Properties) RANDOM (zigzag) movement of particles due to collision

Brownian Movement

COLLOID PROPERTIES (under Kinetic Properties) Movement of particles from an area of HIGH conc to an area of LOW conc

Diffusion

COLLOID PROPERTIES (under Optical Properties) * When a light beam is passed through a colloidal sol, some may be absorbed, some is SCATTERED and the remainder is transmitted undisturbed through the sample * FARADAY Effect: the sol. appears turbid due to light scattering * Sig: measurement PS, shape as the turbidity depends in the size or MOLECULAR WEIGHT of the colloidal material involved MNEMONIC: FRAday, saTURday, MOnday

Light scattering effect

COLLOID PROPERTIES (under Electrical Properties) * Aka electrothermodynamic potential * the difference in electric potential between the ACTUAL of the particle and the ELECTRONEUTRAL region

spirist Potential

COLLOID PROPERTIES (under Electrical Properties) * aka electrokinetic potential * the potential between the surface of the tightly bound layer (known as SHEAR/SLIPPING PLANE) and the electroneutral region of the solution * governs the degree of REPULSION between adjacent, similarly charged, dispersed particles * Sig: STABILITY of suspension * High negative or positive values mean phase STABLE * +50 mV(more stable form) vs +20 mV * -50mV vs 5 mV

Zeta Potential ***

Factor that governs the degree of REPULSION in systems containing dispersed particles

Zeta Potential

INSOLUBLE particles (10-20microns)

Suspensoid

*lowers sedimentation (settling) rate; thickeners *decrease settling

Suspending agent

Ideal Suspension (morse type BE) Properties of a suspension 1. Settle __________ and readily ________ 2. Particle size of suspensoid should remain fairly constant throughout periods of long-standing 3. Pour ___________ and evenly from its container

1. SLOWLY, REDISPERSIBLE 3. READILY

GELS *** 1. water-based gel 2. freeze-dried 3. supercritical drying; extremely low density; Graphene aerogel 4. room temp. or vacuum; vacuum drying

1. Hydrogel 2. Cryogel 3. Aerogel 4. Xerogel

1. Made up of either SMALL inorganic particles or of LARGE organic molecules enclosing and interpenetrated by a LIQUID 2. Rendered jelly-like by the addition of GELLING agents

Gels

REVERSIBLE gel-sol property; thickens when standing, liquefies when shaken

Thixotropy

taking up of liquid WITHOUT increase in volume

Imbibition

taking up of liquid WITH increase in volume (lumaki)

Swelling ***

dispersing medium squeezed out; gel shrinks

Syneresis

Identify what type of Gelatin: Acid hydrolysis

Type A Gelatin

Identify what type of Gelatin: Base hydrolysis

Type B Gelatin