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tablet dosage forms
tablet dosage forms
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11/21/2009

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Term
tablets
Definition
solid dosage form containing medicinal substances with or without suitable dilutents
Term
ideal tablet characteristics
Definition

1. free of defects

2. good mechanical strength

3.  easy to divide dose: grooved/scored

4.  stable:  chemically and physically stable

5.  reproducible:  good content uniformity

6.  predictable release charcteristics

Term
Tablet types/usage
Definition

1. systemic or local

2. sugar coated sct

3. multiple compressed mct

4. film coated fct

5. enteric coated ec

6. orally disintegrating

7. extended release er

Term
sugar coated tablets
Definition
masks taste, can contain colored sugar
Term
multiple compressed tablets
Definition
more than one ingredient compressed in more than one layer
Term
film coated tablets
Definition
drug release to be at a certain time, water insoluble film will slow down drug release
Term
enteric coated
Definition
drug release takes place beyond the bowel
Term
orally disintegrating tablets
Definition
w/wow technology: dissolves w/in 10 seconds
Term
extended release tablets
Definition
slows down release or extend the release to long periods of time
Term
tablets used in oral cavity
Definition

1.  sublingual

2. buccal

3. lozenges

Term
sublingual tablets
Definition
dissolves under the tongue
Term
buccal tablets
Definition

stick it next to the gumline

1.  progesterone/testosterone

Term
lozenges
Definition

candy w/medicine

1. pastilles:  molded

2.  troches:  compressed

Term
tablets to prepare solutions
Definition

1.  effervescent:  mask taste, buffering pH

2.  hypodermic:  parental use

Term
miscellaneous tablet use
Definition

1.  vaginal

2.  implantable

3.  diagnostic

Term
tablet advantages
Definition

1.  accurate dosing

2.  lower cost to mass produce

3.  compact

4.  stable

Term
tablet disadvantages
Definition

1.  mostly inflexible dose:  except scored tablets

2.  can be difficult to swallow

3.  less effective than liquid dosage forms bc of lag time to dissolve

4.  composition could change physical form

Term
Oral administration of tablets
Definition

place on tongue and swallow w/a glass of water

- water is important bc without it, tablet can lodge in esophagus and may cause ulceration

- patients w/gastro esophageal reflux must take w/water and avoid reclining for 1 hour

Term
tablet excipients
Definition
- non drug ingredients in tablets
Term
excipients
Definition

1. diluents

2. binders and adhesives

3.  disintegrants

4. lubricants

5.  antiadherents

6. glidants

7. colors and dyes

8. flavorants and sweetners

9. adsorbents

Term
diluents/fillers/bulking agents
Definition
increases tablet to a workable size
Term
binders/adhesives
Definition
promote granulation process and/or cohesion
Term
disintegrant
Definition
need wetting to bind and wetting to disintegrate
Term
compression and disintegration
Definition

- increasing compression gives a harder tablet

- increasing compression increases disintegration time

- increasing disintegrant decreases disintegration time

 

Term
lubricants
Definition

- reduce friction during the tablet compression process

- are lipophilic compounds

Term
glidants
Definition
promote the flow of the tablet granules or powder
Term
antiadherents
Definition
reduce sticking or adhesion of tablet granules/powders to the punches and dies
Term
coloring agents
Definition
give elegant appearance and identifications
Term
FD&C
Definition
dye
Term
D&C
Definition
dye
Term
External D&C
Definition
dye
Term
lakes
Definition

insoluble form of dyes

- dyes adhered to aluminum hydroxide

Term
Flavoring agents
Definition
Improve taste and acceptability
Term
adsorbents
Definition
hold liquid and form an apparently dry powder
Term
desirable drug properties
Definition

crystalline form

 

particle size and segregation

 

moisture content

Term

crystalline forms

polymorphisms can affect

Definition

solubility

 

dissolution

 

absorption

Term
particle size and segregation of mixtures can effect
Definition
non uniform size will result in no content uniformity
Term
importance of moisture content
Definition
critical levels are important for a tablet w/out faults
Term
Testing drug excipient compatability
Definition

DSC machine: differential scanning colorimeter

- studies how much degredation is taking place

- interaction = signifcant degredation, much change excipient (one melting point in the middle)

- no interaction = no degredation, we can use excipient (2 different melting points)

Term
types of tablets manufactured
Definition

molded

 

compressed

Term
molded
Definition

no longer molded actually "extrude"

- make dough and then extrude through press

(like making pasta noodles)

Term
compressed tablets
Definition
made by applying pressure on powders or granules using punches and dies
Term

Steps in tablet manufacturing

(each step in process is unit operation)

Definition

1. weighing:  wet/dry/dc

2. particle size reduction:  wet/dry/dc 

3. blending: wet/dry/dc

4. wetting and dough formation: wet

5. extruding: wet

6. drying: wet

7. screen: wet/dry

8. lubricant: wet/dry/dc

9. compression: wet/dry/dc

Term
wet granulation
Definition

1. grind drug:  reduce particle size

2. blend:  w/diluents, distinegrants, binders

3. agglomerate: add liquid to make dough

4. pellet: press it though a mesh and get pellets

5. dry: dry pellets in oven

6. screen: filter out uniform size

7. blend: add lubricant to help w/flow properties of granules

8. compress: into a tablet

 

Term

dry granulation

(slugging)

Definition

1. grind: reduce particle size

2. blend: w/diluents, disintegrants, binders

3. slugging & compacting: get a pellet

4. crush: get granules

5. screen: weed out uniform granules

6. blend: add lubricant to help w/flow properties of granules

7. compress: into a tablet

Term

direct compression

 

Definition

1. grind

2. blend: w/diluents, disintegrants, binders

- adjuvants: di-tab + others

- avicel: microcrystalline cellulose

3. compress

Term
adjuvants
Definition

di-tab

+

others

Term
avicel
Definition
microcrystalline cellulose
Term

punchs and dies

process

Definition

1. lower punch drops down

2. allows powder to fill cavity

3. feed shoe moves powder

4. upper feeds compress powder into tablet

5. upper punch withdrawals

6. lower punch compresses

Term

single punch

(makes #)

Definition
100 tablets/min
Term

rotary punch

(makes #)

Definition
10,000 tablets/min
Term
differnent punches and dies
Definition

spherical

shallow

standard

deep

flat face

caplete

flat face bevel edge

oval

modified ball

Term
molded tablet
Definition

tablets are prepared by forcing wet titurate in to a mold to form the tablets

 

- usually use volatile solvent that will evaporate

- don't use on a commercial scale

Term
coating of tablets
Definition

1. compression coating

2. sugar coating

3. film to protect or delay release

4. enteric coating

5. gelatin coating

6. chocolate or colored coating

 

Term
how to coat tablets
Definition

1. load tablet into tablet coater

2. pan rotate

3. spray solution w/warm air to coat tablet

4. allow solvent suck out via exhaust

5. polish to shine

Term

mutliple compressed tablet

 

Definition

tablets made by more than one compression cycle

- layered tablets

- compression coated tablets

Term
evaluation of tablet (1)
Definition

1. weight variation

2. thickness

3. content uniformity (85-115% strength)

Term
evaluation of tablet (2)
Definition

4. dissolution: specific time, found in monographs (USP guidlines)

 

5. disintegration: solid dosage forms will break into smaller particles

- uncoated: 30 minutes

- coated: up to 2 hours

Term
evaluation of tablets (3)
Definition

6. stability: up to 2 years or more

 

7. hardness:  retain during manufacturing and S&H

- proportional to compaction pressure

(increase pressure = increase harndess)

Term
evaluation of tablets (4)
Definition

8. friability: tablets roll and fall, spin fall apparatus test

- determine weight loss-indication of integrity during handling

Term
fate of tablets
Definition

1. disintegration

2. disintegration of granules

3. dissolution of primary drug particles

4. solvated molecules

5. move into systems

Term

Noyes-Whitney Equation

for dissolution rate

Definition

dC/dt = kS(Cs - Ct)

 

k is dissolution constant

S is surface area of dissolved drug

Cs is saturaton conc. of the drug

Ct is conc. of drug in dissolution medium at time t.

Term
increasing disintegration time by:
Definition

- increasing force of pack = increases hardess

- increasing amount of lubricant = longer to dissolve

 

Term
Types of diluents
Definition

1. cellulose

2. lactose

3. mannitol

4. starch

Term
types of binders/adhesives
Definition

1. starch

2. acacia

3. sodium alginate

4. cellose

5. pvp

(polyvinylpyrrolidine)

Term
types of disintegrants
Definition

1. starch

2. alginates

3. pvp

(polyvinylpyrrolidine)

4. cellulose

Term
cellulose
Definition

diluent

 

binder

 

disintegrant

Term
starch
Definition

diluent

 

binder

 

disintegrant

Term
alginate
Definition

binder

(sodium alginate)

 

disintegrant

Term

pvp

(polyvinylpyrrolidone)

 

Definition

binder

 

disintegrant

Term
types of lubricants
Definition

1. talc

2. stearic acid salts (Na, Mg)

3. surfactants (lipophilic, brig)

4. waxes

Term
types of adsorbents
Definition

1. magnesium oxide

2. bentonite

3. silicon dioxide

Term
molded tablet diluents
Definition

1. lactose

2. sucrose

3. dextrose

4. mannitol

5. kaolin

6. precipitate chalk