MIDTERM 02 - Solid Dosage Forms Flashcards
Intimate mixtures of dry, finely divided drugs and/or chemicals used externally or internally
Powders
Mixtures that liquefy when in close and prolonged contact with one another
Eutectic mixtures
Done to obtain quantitative data on the size, distribution, and shapes of drug and other components to be used in pharmaceutical formulation
Particle size analysis
Particles are passed by mechanical shaking through a series of sieves (Method for particle size analysis)
Sieving
Is made of wire woven cloth from brass, bronze, or other suitable wire
Sieves
Particles are sized through a calibrated grid background or measuring device (Method for particle size analysis)
Microscopy
Measuring the settling velocity of particles (Stokes’ law) (Method for particle size analysis)
Sedimentation rate
Determined by the reduction in light reaching the sensor as it passes through a sensor (Method for particle size analysis)
Light energy diffraction/Light scattering
Pulsed layer is fired through an aerosolized particle spray and photographed in 3 dimensions (Method for particle size analysis)
Laser holography
Particle is driven by an airstream will hit a surface in its path; separated into various size ranges (Method for particle size analysis)
Cascade impaction
A mechanical process of reducing particle size of solids
Comminution
2 types of comminution of drugs (SL)
Small scale, Large scale
3 types of small-scale comminution of drugs (TLP)
Trituration, Levigation, Pulverization by intervention
Process of grinding a drug in a mortar and pestle to reduce its particle size (Types of small scale comminution)
Trituration
Has a non-porous, smooth surface and is used for suspensions and ointments (Types of mortar and pestle)
Glass
Used for crystalline solids (Types of mortar and pestle)
Wedgewood
Used for soft aggregates/crystalline (Types of mortar and pestle)
Porcelain
Not to be used in reactive substance (Types of mortar and pestle)
Metal
Process of separating fine particles from coarse by grinding in water (Types of small scale comminution)
Levigation
Process of reduction of particle size with the aid of a second agent that can be readily removed from the pulverized product (Types of small scale comminution)
Pulverization by intervention
Example of mill & pulverizer used for large scale comminution of drugs
FitzMill comminutor
5 ways of mixing/blending powders (TSGST)
Trituration, Spatulation, Geometric dilution, Sifting, Tumbling
Process of using a spatula on a sheet of paper/ointment tile (Ways of mixing/blending powders)
Spatulation
Used when a small amount of potent substance is mixed with a large amount of diluent (Ways of mixing/blending powders)
Geometric dilution
Process of using sifters; results in a light and fluffy product (Ways of mixing/blending powders)
Sifting
Process that involves that use of a machine/motorized equipment; is time consuming (Ways of mixing/blending powders)
Tumbling (rotating chamber)
Powders used orally and may exert local and systemic effects
Medicated powders
Powders that contain inert propellants and pharmaceutical diluents; used for asthma and other bronchial conditions
Aerosolized powders
2 types of powders (BD)
Bulk powders, Divided powders
Powders that contain non-potent substances; dispensed in bulked quantities (Types of powders)
Bulk powders
Powders that are in the form of individual dosing units; dispensed in chartulae, metal foil, small heat-sealed or resealable plastic bags (Types of powders)
Divided powders
Method used for divided powders with non-potent substances
Block and divide method
Method used for divided powders with potent substances
Geometric dilution
4 types of paper used for powders (SVGW)
Simple bond paper, Vegetable parchment, Glassine, Waxed paper
Opaque paper with no moisture-resistant property (Types of paper used for powders)
Simple bond paper
Thin, opaque, moisture-resistant paper (Types of paper used for powders)
Vegetable parchment
Glazed, transparent, moisture-resistant paper (Types of paper used for powders)
Glassine
Transparent, waterproof paper (Types of paper used for powders)
Waxed paper
Prepared agglomerates of smaller particles of powder
Granules
2 methods of preparing granules (WD)
Wet granulation method, Dry granulation method
Involves moistening the powder/powder mixture and passing the paste through a screen of mesh size to form granules (Types of wet granulation method)
Basic wet method
Particles in conical piece of equipment are dispersed and suspended (Types of wet granulation method)
Fluid bed processing
Use of roll press or roller compactor and a granulating machine (Types of dry granulation method)
Dry method/Fusion method
Compression of a powder or powder mixture under 8000-1200 pounds of pressure (Types of dry granulation method)
Slugging
Tablets formed by slugging that are flat faced and about 2.5 cm (1 in) in diameter
Slugs
Granules or coarse powders containing medicinal agents composed of sodium bicarbonate, citric acid, and tartaric acid
Effervescent granulated salt
2 methods of preparing effervescent granules (DW)
Dry method/Fusion method, Wet method
One molecule of water is present in each molecule of citric acid (Methods of preparing effervescent granules)
Dry method/Fusion method
Source of binding agent is water added to alcohol as the moistening agent, forming a pliable mass for granulation (Methods of preparing effervescent granules)
Wet method
A solid dosage form in which medicinal agents and/or inert substances are enclosed in a small gelatin shell
Capsules
Obtained by the partial hydrolysis of collagen from the skin, white connective tissue, and bones of animals
Gelatin
2 types of gelatin (USP)
Gelatin A, Gelatin B
Type of gelatin obtained from acid hydrolysis
Gelatin A
Type of gelatin obtained from basic hydrolysis
Gelatin B
Are capsules referred to as “DFC” or dry filled capsule; manufactured into two sections, the capsule body and a shorter cap
Hard gelatin capsules
Excipients added in HGC to fill the capsule
Diluents
Example of diluent in HGC
Lactose
Excipients added in HGC to facilitate the flow of powder
Lubricant
Example of lubricant in HGC
Mg stearate
Excipients added to HGC to enhance drug dissolution
Wetting agent
Example of wetting agent in HGC
Li2CO3
2 methods for filling HGC
Punch method, Rolling method
Empty capsule body is held and punched vertically into the powder cake repeatedly until filled (Methods for filling HGC)
Punch method
Using the spatula, fill the capsule by drawing the powder to the capsule body until completely filled (Methods for filling HGC)
Rolling method
2 innovations to provide distinctive looking capsules (PS)
Pulvules, Spansule capsules
End of the body-producing peg is tapered while leaving the cap-making peg rounded (Innovation to provide distinctive looking capsules)
Pulvules
Capsules with the ends of both the bodies and caps highly tapered (Innovation to provide distinctive looking capsules)
Spansule capsules
3 innovations in capsule shell designs (SCC)
Snap-fit, Coni-snap, Coni-snap supro
Two halves of capsule shells positively joined through locking grooves in the shell walls (Innovation in capsule shell designs)
Snap-fit
The rim of the capsule body is tapered slightly (not straight) (Innovation in capsule shell designs)
Coni-snap
The rim is tapered, upper capsule part extends, and opening is difficult (Innovation in capsule shell designs)
Coni-snap supro
Process of sealing the joint between capsule parts
Capsule sealing
Process of fusing the capsule cap to the body through the double wall thickness at their juncture (Methods of capsule sealing)
Heat welding process
Water and ethanol is sprayed around the seam area then thermal bonding (Methods of capsule sealing)
Liquid sealing
Are capsules made of gelatin and used to encapsulate and hermetically seal liquids, suspensions, pasty materials, dry powders, and preformed tablets
Soft gelatin capsules
Process that uses set of molds to form the soft-gelatin capsules
Plate process
Most commonly used process of preparing soft-gelatin capsule; uses a rotary die machine
Rotary die process
Process that uses Norton capsule machine to prepare soft-gelatin capsule; similar to rotary die but differs in encapsulating process
Reciprocating die process
Process that uses Stern machine to prepare soft-gelatin capsule; unlike the others fill dry powders into soft elastic capsules
Accogel capsule machine
Are solid dosage forms prepared by compression with the aid of suitable pharmaceutical excipients
Tablets
3 methods of manufacturing tablets (WDD)
Wet granulation, Dry granulation, Direct compression
Widely employed method for manufacturing compressed tablet (Methods of manufacturing tablets)
Wet granulation
2 types of all-in-one granulation methods (FM)
Fluid bed granulator, Microwave vacuum process
Involves continuous operation (Types of all-in-one granulation method)
Fluid bed granulator
Using a microwave, powder is mixed, wetted, agglomerated, and dried (Types of all-in-one granulation method)
Microwave vacuum process
Powder mixture is compacted in large pieces/slugging and broken down or sized into granules (Method of manufacturing tablets)
Dry granulation
Process wherein after weighing and mixing the ingredients, the powder mixture is slugged or compressed into large flat tablets or pellets
Slugging
Process wherein powder compactors are used to increase the density of powder by pressing it between roller at 8000-1200 pounds of pressure
Roller compaction
Compressed directly in a tablet machine without a need for granulation (Method of manufacturing tablets)
Direct compression
Fillers to make up the bulk of the tablet (Types of tablet excipients)
Diluent
Either dry or liquid form to promote granulation process or cohesive compacts during direct compression process (Types of tablet excipients)
Binders & adhesives
Facilitates tablet disintegration (Types of tablet excipients)
Disintegrants
Reduce friction during tablet ejection between the walls of tablet and die cavity (Types of tablet excipients)
Lubricants, antiadherents & glidants
Disguise off-color drugs to provide product ID and to produce a more elegant product (Types of tablet excipients)
Color & dyes
Limited to chewable tablets or tablets intended to dissolve in the mouth (Types of tablet excipients)
Flavoring agents
Only for chewable tablets or tablets intended to dissolve in the mouth (Types of tablet excipients)
Artificial sweeteners
Hold quantities of fluid in an apparently dry state (Types of tablet excipients)
Adsorbents
Are formed by compression and have no special coating (Types of tablets)
Compressed
More than a single compression; results to a multi-layered tablet (Types of tablets)
Multiple compressed
Compressed tablet with colored or uncolored sugar layer (Types of tablets)
Sugarcoated
Coated with a thin layer of polymer, forming a skin like film over the tablet (Types of tablets)
Film coated
A capsule-shaped compressed tablet with gelatin that is 1/3 smaller than a capsules (Types of tablets)
Gelatin coated
Its outer layer or shell provides an initial drug dose that rapidly disintegrates in the stomach (Types of tablets)
Repeat-action
Disintegrates in the intestines; is destroyed by gastric acid (Types of tablets)
Delayed-action/Enteric coated
Used for extemporaneous preparation in the pharmacy; contains large amount of potent drug substance (Types of tablets)
Dispensing/Compounding
Flat, oval tablet to be dissolved in the buccal pouch or under the tongue (Types of tablets)
Buccal/Sublingual
Dissolve slowly in the mouth and provide local effects (Types of tablets)
Troches, Lozenges, Dental cones
Dissolves in the mouth; has a creamy base made of flavored mannitol (Types of tablets)
Chewable
Releases gas when it comes into contact with water (Types of tablets)
Effervescent
Is very soft and small; designed for rapid dissolution (Types of tablets)
Molded
Are used by physicians to prepare injections; must be rendered sterile (Types of tablets)
Hypodermic
2 tablets withdrawn from the market (HD)
Hypodermic, Dispensing
Are made by compressing a formulation containing a drug or drugs with excipients on stamping machine called presses
Tablet compression machine tablets
For holding and feeding granulation (Components of tablet presses)
Hopper
Define the shape and size of the tablet (Components of tablet presses)
Dies
For compressing the granulation within the dies (Components of tablet presses)
Punches
For guiding the movement of the pouches (Components of tablet presses)
Cam tracks
For moving granulation from hopper into the dies (Components of tablet presses)
Feeding mechanism
Partial or complete separation of the top or bottom crowns of a tablet from the main body of the tablet (Problems encountered in tablet production)
Capping
Separation of a tablet into 2 or more distinct layers (Problems encountered in tablet production)
Splitting/Lamination
Adhesion of tablet material to a die wall (Problems encountered in tablet production)
Sticking
Removal of tablet’s surface by a punch (Problems encountered in tablet production)
Picking
Unequal distribution on a tablet with light or dark areas standing out on an otherwise uniform surface (Problems encountered in tablet production)
Mottling
3 ways of imprinting logos/ID on tablets (DEE)
Debossed, Embossed, Engraved
Imprinted with a mark below the surface (Ways of imprinting logos/ID on tablets)
Debossed
Imprinted with a mark raised above the surface (Ways of imprinting logos/ID on tablets)
Embossed
Imprinted with a code that is cut into the surface during production (Ways of imprinting logos/ID on tablets)
Engraved
Spray coating of powders, granules, beads, pellets or tablets held in suspension by a column of air
Fluid bed/Air suspension coating
Process where the items to be coated are fed into a vertical cylinder and supported by a column of air that enters from the bottom of the cylinder
Wurster process
3 types of fluid bed system (TTB)
Top sprays, Tangential spray technique, Bottom spray
Provides greater capacity, up to 1,500 kg than the other air suspension coating method (Types of fluid bed system)
Top sprays
Used in rotary fluid bed coater; used for layering coating (Types of fluid bed system)
Tangential spray technique
Used for sustained-release and enteric-release products (Types of fluid bed system)
Bottom spray
Device that measures the degree of force required to break a tablet
Tablet hardness tester
Device that determines a tablet’s friability (The tablet’s tendency to crumble)
Friabilators
Process that ensures that the tablet drug substance is available for dissolution and absorption from the GIT
Disintegration
Solid dosage form that can be made by compression or molding; is made by using a tablet machine and large, flat punches
Lozenges
Is a raspberry lollipop that is a sugar based lozenge on a stick that contains fentanyl citrate; its effect lasts about 15 minutes
Fentanyl Actiq
Are small, round, solid dosage forms containing a medicinal agent and intended to be administered orally
Pills
Are semi-solid dosage forms used for insertion into the body orfices
Suppositories
Cylindrical and tapered at one end; bullet shaped (Types of suppositories)
Rectal suppository
Globular, oviform, or conical in shape (Types of suppositories)
Vaginal suppository (Pessaries)
Pencil-shaped (Types of suppositories)
Urethral suppository (Bougies)
Suppository that relieves constipation or pain, irritation, itching, and inflammation
Rectal suppository
Suppository that has a laxative action by irritating the mucous membrane through its dehydrating action
Glycerin suppository
Suppository that acts as contraceptives and antiseptic in feminine hygiene; has specific agents to combat invading pathogens
Vaginal suppository
Suppository that is an antibacterial and serves as a local antiseptic preparatory to urethral examination; also a contraceptive agent
Urethral suppository
Used for relief of asthma (Examples of rectal suppository)
Aminophylline, Theophylline
Used for nausea and vomiting and as tranquilizers (Examples of rectal suppository) (PC)
Prochlorphenazine, Chlorpromazine
Used as a sedative and hypnotic (Examples of rectal suppository)
Chloral hydrate
Used as a narcotic analgesic (Examples of rectal suppository)
Oxymorphone HCl
Used as an analgesic and antipyretic (Examples of rectal suppository)
Aspirin
Examples include cocoa butter, Wecobee base, and Witepool base (Types of suppository bases)
Fatty/Oleaginous bases
Fatty/oleaginous base derived from coconut oil
Wecobee base
Fatty/oleaginous base derived from saturated fatty acids (C12-C18)
Witepool base
A triglyceride primarily of oleopamitostearin and oleodistearin; is an ideal suppository base that melts between 30-36°C
Cocoa butter
Examples include glycerinated gelatin and polyethylene glycols (Types of suppository bases)
Water soluble/Water miscible bases
Have the tendency to absorb moisture due to the hygroscopic nature of glycerin
Glycerinated gelatin
Are polymers of ethylene oxide and water, prepared to various chain length, MWs, and physical states
Polyethylene glycols
A mixture of oleaginous and water-miscible materials (Types of suppository bases)
Miscellaneous bases
Method of suppository preparation commonly employed in small scale and industrial scale
Molting from melt/Fusion method
Tablet made of dried sodium biphosphate, NaHCO3, and starch
Carbon dioxide releasing tablet
Tablet that contains active ingredients and lactose and/or phosphoric acids for adjusting the acidity of the vagina to pH 5
Vaginal compressed tablet
Inserts/tablets that are most widely used than vaginal suppositories; are easier to manufacture and more stable and less messy
Vaginal inserts/tablets
Base/filler in vaginal inserts/tablets
Lactose
Dispersing agent in vaginal inserts/tablets
Polyvinylpyrrolidone (PVP)
Disintegrating agent in vaginal inserts/tablets
Starch
Lubricant in vaginal inserts/tablets
Mg stearate
Are solid substances that absorb moisture from the atmosphere until they dissolve in the absorbed water and form solutions
Deliquescent substances
Are solid substances that can undergo spontaneous loss of water from hydrated salts
Efflorescent substances
Are solid substances that can absorb water from its surroundings
Hygroscopic substances
If only __________ is used in effervescent granulated salts, it will be readily loose firm & crumble
Tartaric acid
If only __________ is used in effervescent granulated salts, it will result in a sticky paste
Citric acid