prelim 3.2 - manufacture of tablets

Multistage process (Sugar coating or film coating)

Sugar coating

Usually single stage (Sugar coating or film coating)

Film coating

Batch coating time - 8 hours or longer (Sugar coating or film coating)

Sugar coating

Batch coating time - 1.5-2 hours (Sugar coating or film coating)

Film coating

Functional coatings - Not usually possible apart from enteric coating (Sugar coating or film coating)

Sugar coating

Functional coatings - Easily adaptable for controlled release (Sugar coating or film coating)

Film coating

Oldest form of pharmaceutical coating for manufacturing small, coated particles or tablets (Application of coating materials)

Pan coating

Anhydrous operation wherein the powder or granular coating material is compressed onto a tablet core of drug with a special tablet press (Application of coating materials)

Compression coating

Is accomplished by suspending solid particles of core material in an upward-moving stream of air, which may be heated or cooled (Application of coating materials)

Air suspension coating

Marking of a capsule or tablet surface for the purpose of product identification (Other unit operations)

Printing

To protect the tablet from extreme conditions and to facilitate the shipping and distribution of the medicine until it reaches the patient (Other unit operations)

Packaging

Direct contact with the product or direct effect on shelf-life; immediate container (Types of packaging)

Primary

External to the primary pack; cartons, corrugated shippers, pallets (Types of packaging)

Secondary

Protects the containers from extraneous solids from loss of article under ordinary conditions (Classification of containers - protection ability)

Well-closed

Reclosable; protects the contents from extraneous solids, liquids, and vapors (Classification of containers - protection ability)

Tight

Impervious to air or any other gases; used for parenteral (sterile) preparations (Classification of containers - protection ability)

Hermetic

Amber bottle (Classification of containers - protection ability)

Light resistant

Single dose only; for parenteral administration; USP limit is 1000 mL (Classification of containers - quantity held)

Single-unit

Multiple dose; USP limit is 30 mL (Classification of containers - quantity held)

Multiple-unit

Highly resistant borosilicate neutral gas (Official glass types)

Type I

Treated soda-lime surface-treated soda glass (Official glass types)

Type II

Soda-lime soda or alkali glass (Official glass types)

Type III

General purpose soda-lime (Official glass types)

Type NP

For buffered and non-buffered aqueous solutions; for all purpose (Official glass types)

Type I

For buffered aqueous solutions of pH less than 7 (Official glass types)

Type II

Dry powders or substances and oily or oleaginous solutions (Official glass types)

Type III

Oral solid and liquid dosage forms and external preparations (Official glass types)

Type NP

Powdered glass test (Official glass types)

Type I, III, NP

Water attack test (Official glass types)

Type II

Caps; low, medium, and high-density (Plastic and plastic containers)

Polyethylene

PET (Plastic and plastic containers)

Polyethylene terephthalate

General purpose and impact modified (Plastic and plastic containers)

Polystyrene

Homopolymer and copolymer; caps, outer wrappings, autoclavable (Plastic and plastic containers)

Polypropylene (PP)

Plasticized and unplasticized; blister packaging (Plastic and plastic containers)

Polyvinyl chloride (PVC)

One that is difficult for most children under 5 years of age to open or gain access to the contents or obtain a harmful amount of the contents (Plastic and plastic containers)

Child-resistant

Uses an indicator or barrier to entry that provide visible evidence to consumers that tampering has occurred (Plastic and plastic containers)

Tamper-resistant/Evident

The only true tamper-resistant container

Aerosol

A measure used to describe a packing of particles or granules (IPQCT)

Bulk density

Mechanical tapping is achieved by raising the cylinder or vessel and allowing it to drop under its own weight a specified distance (IPQCT)

Tapped density

To assure that the weights of the sampled tablets are within the tolerances (true for uncoated tablets) (FPQCT)

Tablet weight

Average weight - <130 mg (Max % difference allowed)

±10%

Average weight - 130-324 mg (Max % difference allowed)

±7.5%

Average weight - >324 mg (Max % difference allowed)

±5%

Provides an idea whether the dose in a batch of units is uniform and if the dosage form can deliver the right amount of dose in each patient (FPQCT)

Weight variation

Provides information on the variation within or between lots and determines the maximum packaging quantity of a dosage form (FPQCT)

Tablet thickness

Equipment used for tablet thickness test

Vernier caliper

To test if tablet has adequate strength to withstand the rigors of mechanical shocks encountered in the production, packaging, shipping, & dispensing (FPQCT)

Tablet hardness

Tablet hardness affects __________, __________, and __________ (DDB)

Dissolution, Disintegration, Bioavailability

Uses a spring applied diametrically to a heat (Tablet hardness tester)

Stokes-Monsanto

Force produced by a manually operated air pump; hydraulic pressure (Tablet hardness tester)

Strong Cobb

Pliers (Tablet hardness tester)

Pfizer

Use of suspended motor-drive weight (Tablet hardness tester)

Erweka

Motor-driven anvil crushes tablet horizontally; motorized test jaw (Tablet hardness tester)

Schleuniger

Hardness - 4-10 kg (Type of tablet)

Conventional tablets

Hardness - 7-10 kg (Type of tablet)

Buccal tablets

Hardness - 2-3 kg (Type of tablet)

Chewable/SL tablets

Hardness - >10 kg (Type of tablet)

MR tablets

Shows how well a tablet resists chipping and crumbling when external stresses are applied (FPQCT)

Friability test

Instrument used in friability test

Friabilator

A friabilator utilizes a plastic chamber that revolves at __________, dropping the tablets a distance of 6 inches with each revolution

25 rpm

A friabilator utilizes a plastic chamber that revolves at 25 rpm, dropping the tablets a distance of __________ with each revolution

6 inches

In friability test, a maximum mean weight loss from the three samples of NMT __________ is considered acceptable for most products

1.0%

To assure that the dosage form breaks down into smaller particles or granules (FPQCT)

Disintegration test

Apparatus used in disintegration test

Basket rack assembly

Temperature used in disintegration test (Settings)

37°C ± 2°C

Number of cycles used in disintegration test (Settings)

29-32 cycles/min

Sample size used in disintegration test (Settings)

6 tablets

In disintegration test, __________ of the tablets should disintegrate completely

All

In disintegration test, if 1 or 2 tablets fail to disintegrate completely, repeat the test for _________ additional tablets

12

In disintegration test, the requirement is met if NLT __________ of the total 18 tablets tested have disintegrated

16

Water: 30 minutes (Tablet)

Plain, coated tablet and capsules

Water: 5 minutes soaking; simulated gastric juice: 1 hour; simulated intestinal juice: as specified in the monograph (1 hr usually) (Tablet)

Enteric coated tablet

Water: 4 hours (Tablet)

Buccal tablet

Water: 3 minutes (or as specified in the monograph) (Tablet)

SL tablets

To evaluate as to whether or not a tablet releases its drug contents when placed in the environment of the GI tract (FPQCT)

Dissolution test

To evaluate a tablet’s potential for efficacy; amount of drug per tablet needs to be monitored from tablet to tablet and batch to batch (FPQCT)

Assay

Designed to determine the shelf life or expiry date of a product (FPQCT)

Stability

Visually observe the presence of chips, cracks, contamination from foreign substances, surface texture, and appearance (FPQCT)

Appearance

When the upper or lower segment of the tablet separates horizontally; due to air-entrapment (Tablet defects)

Capping

Separation of a tablet into two or more distinct horizontal layers; due to air-entrapment (Tablet defects)

Lamination

Breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operations; due to incorrect machine settings (Tablet defects)

Chipping

Capping, lamination, and cracking are tablet defects related to __________

Tableting processes

Chipping, picking, sticking, and binding are tablet defects related to __________

Excipients

Mottling is a tablet defect that is related to __________

More than one factor

Double impression is a tablet defect that is related to __________

Machine

Small, fine cracks observed on the upper and lower central service of tablets; result of rapid expansion (Tablet defects)

Cracking

Refers to the tablet material adhering to the die wall; due to improperly dried or lubricated granules (Tablet defects)

Sticking

Is a slow form of sticking and is largely due to excess moisture in the granulation (Tablet defects)

Filming

When a small amount of material from a tablet is sticking to and being removed off from the tablet surface by a punch face; improper drying (Tablet defects)

Picking

Unequal distribution of color on a tablet; due to uneven, incomplete mixing (Tablet defects)

Mottling

Involves only those punches, which have a monogram or other engraving on them; occurs when punch rotates (Tablet defects)

Double impression

A local detachment of film from the substrate forming blister; due to entrapment of gases (Coated tablet defects)

Blistering

It is the defect of the film coating whereby volcanic-like craters appears exposing the tablet surface (Coated tablet defects)

Cratering

Is is the defect where isolated areas of film are pulled away from the surface when the tablet sticks together and then part (Coated tablet defects)

Picking

It is the defect whereby pits occur in the surface of a tablet core without any visible disruption of the film coating (Coated tablet defects)

Pitting

It is the defect where coating becomes dull immediately or after prolonged storage at high temperatures (Coated tablet defects)

Blooming

It is the defect best described as whitish specks or haziness in the film (Coated tablet defects)

Blushing

A defect which involves variation in color of the film (Coated tablet defects)

Color variation

It is the defect that renders the intagliations indistinctness (Coated tablet defects)

Infilling

It is the surface defect resulting in the film being rough and nonglossy; appearance is similar to that of an orange (Coated tablet defects)

Orange peel (roughness)