Tablets

Front 1

Define Tablets

Back 1

Solid dosage form prepared by compression or molding of powdered/granulated drugs with the aid of excipients,

Front 2

Tablets are the most what type of dosage form?

Back 2

Simplest

Front 3

5 main characteristics of tablets

Back 3

1) most frequently prescribed commercial dosage form
2) stable, elegant, effective
3) convenient for handling, identification, administration
4) Commercially available in only fixed dosage strengths
5) many formats, sizes, colors, shapes, scored in halves, elegant engravings

Front 4

The format and size are determined by what? (3)

Back 4

Size of die and punch, amount of fill, amount of pressure applied to fill

Front 5

All tablets most have identification imprints except what 3 solid dosage forms?

Back 5

1) OTC vitamins
2) radioactive
3) clinical trial drugs

Front 6

What are compressed tablets?

Back 6

Single compression of all ingredients

Front 7

What are multiple compressed tablets? And what are the 2 main types?

Back 7

For separation of incompatible drugs or for modified release.
Multiple-layered tablets: multiple feed and multiple compression of fill within a single die
Tablet-within-a-tablet: core tablet is placed within the die for compression with surrounding fill (internal and external layers)

Front 8

Define sugar-coated tablets and general characteristics (5)

Back 8

Tablets with several layers of colored/uncolored sugar solutions of sugar, gelatin, acacia or PVP (polyvinylpyrrolidone)
1) uses time and expertise
2) final tablet is increased up to 50% original size and weight
3) imprinting from FDA 1995 --> product-specific identification codes
4) Polishing with cloth or canvas impregnated with carnauba wax (palm tree) or beeswax or spraying with wax dissolved in acetone
5) final tumbling with talc for luster

Front 9

Define film-coated tablets

Back 9

Thin layer of aqueous or non-aqueous polymer solution (plastic-like) of cellulose acetate phthalate or cellulose ether polymers --> not digestible

Front 10

Define gelatin-coated tablets

Back 10

"Caplets"
Capsule-shaped compressed tablet coated with gelatin

Front 11

Define enteric coated tablets

Back 11

Shellac, pthalate derivatives coated onto the whole tablet, drug particles or granules in a single or multiple layer

Front 12

Enteric coated tablet characteristics (3)

Back 12

1) protection of drug, patient gastric mucosa or enhanced absorption
2) based on transit time for passage from stomach to intestine OR based on pH environment
3) delayed-release features

Front 13

Define buccal tablets

Back 13

Placed in cheek pouch, dissolve slowly (compressed softer), absorption through oral mucosa

Front 14

Define sublingual tablets

Back 14

placed under the tongue, prompt dissolution, absorption through oral mucosa

Front 15

Define chewable tablets

Back 15

chewed/dissolved in the mouth made with a creamy base of high MW sugars (mannitol, sorbitol, xylitol) that have a negative heat of solution (leaves cool mouth feeling)
Can be colored and flavored and good for those with issues swallowing whole tablets

Front 16

Define lozenges, troches, drops and pastilles

Back 16

hard candy-like (sugar or sugar-free) or gummy like (gelatin-based)
Dissolve slowly in oral cavity due to high compression of heat stable active ingredients
Used for local effects

Front 17

Define lollipops

Back 17

sugar-based lozenge on a stick (sugar-free options)
Ex: fentanyl Actiq for breakthrough chronic cancer --> analgesic and anesthetics

Front 18

Define effervescent tablets

Back 18

NOT TO BE SWALLOWED WHOLE
compression of effervescent salts that liberate CO2 when dissolved in water

Front 19

Define Molded tablets

Back 19

molding and soft compaction, hand=operated tablet press
Difficult to get homogeneity in each tablet

Front 20

Define tablet triturates

Back 20

"Old-fashioned" tablets containing small amounts of potent drugs prepared by minimum compression to allow for crushing in compounding or rapid dissolution

Front 21

Define RDT (Rapid Dissolving Tablets)

Back 21

Tablets using super-disintegrants so it dissolves within 15-30 seconds and patient swallows liquid
Good for children and the elderly

Front 22

What type of excipients are used and what are 3 inherent problems with RDT?

Back 22

Very water-soluble excipients that attract water into the tablet
Problems: drug loading, masking taste, friability

Front 23

2 examples of RDT technology

Back 23

1) Zydis --> lyophilization (foaming of ingredients and poured into mold)
2) DuraSolv, OraSolv, Flashtab, Wowtab --> compression (super-disintegrants + small quantity of effervescent material)

Front 24

Define XR tablets

Back 24

Release of medication in a pre-determined manner over an extended period of time
Tablet contains multiple doses in single dosage unit
Additional FDA testing to make sure tablet does not dump drug into body

Front 25

What are the 8 steps in wet granulation preparation of compressed tabs?

Back 25

1) weight and blend powdered ingredients
2) sift to eliminate clumps
3) mix with liquid binder or adhesive mixture
4) damp mass passed through mesh screen (6-8 size) to form granules
5) granules dried in oven
6) sifted in mesh of 12-20 size
7) granules + dry lubricant
8) compression using tablet machine

Front 26

What are 2 types of liquid binders used?

Back 26

1) 10-20% hydroalocholic solution of cornstarch + PVP (povidone)
2) 25-50% solution of either a: glucose, molasses and gums or b: solution of cellulose derivatives and gelatin

Front 27

What are types of dry lubricants used in wet and dry granulations for compression of tabs used?

Back 27

1) Mg/Ca/Zn Stearates
2) talc
3) stearic acid: wet only

Front 28

What are the 2 types of compression machines?

Back 28

1) single-punch tablet press
2) rotary tablet machine with multiple punches

Front 29

Describe all-in-one-granulation method

Back 29

Machine does both granulation and compression steps
Granulation prepared by fluid-bed or microwave vacuum process

Front 30

What is dry granulation used for?

Back 30

Drug/materials that are degraded in presence of moisture or high heat

Front 31

What are the 6 steps of dry granulation?

Back 31

1) Weigh and blend powdered ingredients (some should have cohesive properties)
2) mix with binding agents
3) powders compressed into slugs
4) slugs crushed and sized in screen
5) granules + dry lubricant
6) compression in machine

Front 32

What are the types of dry binders used?

Back 32

6-12% of methycellulose or hydroxyl-methylcellulose

Front 33

What is direct compression?

Back 33

No granulation step, excipients have free-flowing properties and cohesive properties (no binding agent or lubricant needed)
Uses potassium chloride, methenamine (most common), dibasic calcium phosphate

Front 34

What is molding?

Back 34

Forcing damp mass into cavities of a tablet mold, lots of room for non-uniformity

Front 35

What is tablet dedusting?

Back 35

Removes loose powder of tablets for elegance prior to coating by using vacuum

Front 36

What is tablet coating and the 3 main types?

Back 36

Protects drug from air and humidity and to protect mucosa from irritating drugs, also masks taste
Helps provide aesthetics and distinction to a product
Types: sugar-coated, enteric coated, film coated

Front 37

Quality control of USP: weight

Back 37

determined by quantity of fill in die of press, weight variation using average weight of 10 tabs

Front 38

Quality control of USP: content uniformity

Back 38

10 tabs, active ingredients between 90 - 110% in every drug

Front 39

Quality control of USP: hardness, breaking strength, friability

Back 39

measurement of pressure to break each tablet (should be around 4kg), depends on type of tablet and degree of compression
Friability: measures tendency of tablet to crumble, must be less than 1% loss in machine

Front 40

Quality control of USP: thickness

Back 40

depends on diameter of die, amount of fill, compaction characteristic of fill, pressure applied

Front 41

Quality control of USP: disintegration

Back 41

time required for a tablet to disintegrate
Compressed tablet into water at 37 celsius (30 min) or gastric fluid (1 hour)
OR
Enteric-coated tablet into stimulated gastric fluid (1hr, no disintegration) and then intestinal fluid

Front 42

Quality control of USP: dissolution

Back 42

In vitro testin, product development, quality assurance during manufacturing, bio-equivalence from batch-to batch for scale-up, mandatory for FDA, influences absorption and bioavailability

Front 43

Packaging and Storage of Tablets

Back 43

Light-resistant containers: bottles, blisters of plastic, or plastic + aluminum
Desiccant packet + cotton ball