BY PACKAGING


Films, Foils, and Laminate

Regenerated cellulose film based on viscose ( chemical used for manufacturing of rayon) & laminating two or more types of films, cellulose coatings, foil and paper play diff roles such as supportive, barrier, heat seal & decorative.

For Example:

  • Aluminum foil even in the thinnest gauges offers the best barrier properties, which are not approached even by the most impermeable plastics.
  • Metallization”: A relatively new process whereby particles of metal are laid down onto a surface under vacuum, can significantly improve the barrier properties of a material but these do not approach the properties of a pure foil.

In the newer technology “Co-Extrusion”, a number of plastic plies are extruded in combination to produce cheaper laminations.

Uses of films, foils, laminations:

  • Strip packs
  • Blister packs
  • Sachets
  • Diaphragm seals for bottles
  • Liners for boxes either attached or loose bag-in-box systems & bags.

Qualification and Quality Control of Pharmaceutical Packaging Components

Degree of Concern Associated with the Route of Administration

PACKAGING COMPONENT – DOSAGE FORM INTERACTION

HIGH

MEDIUM

LOW

HIGHEST

Inhalation Aerosol and Solution; Injectables

Sterile powder and powder for injecton

 

HIGH

Ophthalmic solution and suspension, Transdermal patches, Nasal sprays

 

 

LOW

Topical solution and suspension

Aerosol, Oral solution and Suspension

Topical Powders

Oral Powders

Oral Tablets and Capsule

 

Typically Suitability Consideration for Common Classes of Drug Product

 

Protection

Compatibility

Safety

Performance/Drug Delivery

Inhalation Aerosols and Solutions, Nasal Sprays

L, S, M, W,G

Case 1c

Case 1s

Case 1d

Inhalation Powders

L, W, M

Case 3c

Case 5s

Case 1d

Injections, Injectable Suspensions

L, S, M, G

Case 1c

Case 2s

Case 2d

Sterile Powders and Powders for Injection

L, M, W

Case 2c

Case 2s

Case 2d

Ophthalmic Solutions and Suspensions

L, S, M, G

Case 1c

Case 2s

Case 2d

Topical Delivery Systems

L,S

Case 1c

Case 3s

Case 1d

Topical Solutions and Suspensions, and Topical and Lingual Aerosols

L,S, M

Case 1c

Case 3s

Case 2d

Topical Powders

L, M, W

Case 3c

Case 4s

Case 3d

Oral Solutions and Suspensions

L, S, M

Case 1c

Case 3s

Case 2d

Oral Powders

L,W

Case 2c

Case 3s

Case 3d

Oral Tablets and Oral Hard and Gelatin Soft Capsules

L, W

Case 3c

Case 4s

Case 3d

 

Protection

            L – protects from light, if appropriate

            S – protects from solvent loss/leakage

            M – protects sterile products or those with microbial limits from microbial contamination

            W – protects from water vapor, if appropriate

            G – protects from reactive gases, if appropriate

Compatibility

  • Case 1c – Liquid-based dosage form that conceivably could interact with its container closure systems components.
  • Case 2c – Solid dosage form until reconstituted; greatest chance for interaction with its container closure system components.
  • Case 3c – Solid dosage form with low likelihood of interacting with its container closure system components.

Safety

  • Case 1s – Typically provided are USP Biological Reactivity Test data, extraction/toxicological evaluation, limits on extractables, and batch-to-batch monitoring of extractables.
  • Case 2s – Typically provided are USP Biological Reactivity Test data and possibly extraction/toxicological evaluation.
  • Case 3s – Typically, an appropriate reference to the indirect food additive regulations is sufficient for drug products with aqueous-based solvents. Drug products with non-aqueous bases solvent systems or aqueous based systems containing co-solvents generally require additional suitability information.
  • Case 4s – Typically, an appropriate reference to the indirect food additive regulations is sufficient.
  • Case 5s – Typically, an appropriate reference to the indirect food additive regulations for all components except the mouthpiece for which USP Biological Reactivity Test data is provided.

Performance

  • Case 1d – Frequently a consideration.
  • Case 2d – May be a consideration.
  • Case 3d – Rarely a consideration.