Choosing the Correct Container

Advantages:

1. Superior protective qualities
2. Economical
3. Readily available in a wide variety of sizes & shapes
4. Essentially chemically inert, impermeable, strong and rigid
5. Has FDA clearance
6. Does not deteriorate with age
7. Provides an excellent barrier against every element except light with a proper closure system. Colored glass, especially amber, can give protection against light.

Disadvantages:

1. Fragility
2. Heavy Weight.

Composition of glass

1. Sand – pure silica
2. Soda-ash – sodium carbonate
3. Limestone – calcium carbonate
4. Cullet – broken glass that is mixed with the batch & acts as a fusion agent for the entire mixture.

The most common cations found in pharmaceutical glassware are silicone, aluminum, boron, sodium, potassium, calcium, magnesium, zinc & barium. The only anion of consequence is oxygen.

Type I: Borosilicate Glass

Type II: Treated Soda-Lime Glass

Type III – Regular Soda-Lime Glass

Type NP – General Purpose Soda-Lime Glass

 

PACKAGE TYPE	TYPE OF FORMULATION CAN BE PACKED	MINIMUM QUALITY OF GLASS THAT CAN BE USED
Ampoule	Aqueous Injectables Of Any pH	Type I
	Aqueous Injectables Of pH Less Than 7	Type II
	Non-Aqueous Injectables	Type III
Vial	Aqueous Injectables Of Any pH	Type I
	Aqueous Injectables Of pH Less Than 7	Type II
	Non-Aqueous Injectables	Type III
	Dry Powders For Parenteral Use (Need To Be Reconstituted Before Use)	Type IV
Bottles and Jars	Tablets, Capsules, Oral Solids & Other Solids For Reconstitution	Type IV
	Oral Liquids (Solutions, Suspensions, Emulsions)	Type IV
	Nasal & Ear Drops	Type IV
	Certain Types Of External Semisolids (Rubeficients, Local Irritants)	Type IV
	Blood & Related Products	Type I

 

Advantages:

1. Ease of manufacturing
2. Available in various types of quality
3. Freedom of design to which they lend themselves
4. Extremely resistant to breakage

Dosage Form – Plastic Interactions / Limitations of Plastic Materials:

1. Permeation
2. Leaching
3. Sorption
4. Chemical modification
5. Alteration on the properties of plastics or product

1. Permeation
   • The transmission of gases, vapors or liquids from the surrounding environment into the plastic container is known as “Permeation”.
   • Permeation of water vapor & oxygen through the plastic wall into the dosage form can be problematic if the drug is sensitive to hydrolysis and/or oxidation.
   • An increase in temperature, increases permeability of gases.
   • An increase in crystallinity of the material decreases permeability.
   • Hydrophilic plastic materials such as nylon are poor barriers to water vapor, while hydrophobic materials like polyethylene are better barriers.
   • The concentration of drugs in formulations containing volatile ingredients might change when stored in plastic containers because of the permeation of one or more volatile ingredients through the walls of the plastic containers.
2. Leaching:
   • Release of a constituent from the plastic material of the container into the formulation is known as “leaching”.
   • For example, particular dyes which are used as coloring agents may migrate into a product, contaminates the product and may cause a toxic effect.
3. Sorption:
   • The Process of extraction / removal of one or more of the constituents from the formulation by the packaging material are referred to as “Sorption”.
   • Becomes a serious problem particularly for dosage forms that contain drug and/or other important ingredients in the solution form.
   • May significantly affect the therapeutic efficacy of the formulation containing highly potent drug.
4. Chemical reactivity:
   • Certain ingredients used in plastic container manufacturing may chemically react with one or more components of a drug product.
   • These chemically incompatible substances may also alter the appearance of the plastic or formulation.
5.   Modification:
   • The physical or chemical alteration of the packaging material by the drug product is called “modification”.
   • The content may extract the plasticizer, antioxidant or stabilizer, thus changing the flexibility of the container.
   • Permeation, sorption or leaching may also alter the properties of the plastic container. For example: (1) Oils have a softening effect on polyethylene; (2) Fluorinated hydrocarbons attack polyethylene & PVC.

 

PACKAGE TYPE	FORMULATION	REMARKS
Strip, blister	Tablets, capsules	Polymer coated aluminum with various thickness are available to improve sealability of the pack and the stability of the product.
Collapsible tubes	Ointments, creams, gels and other semisolids	The tubes with internal protective coating of polymers with spike and without spike.
Cans	Aerosols, inhalers, sprays	Pressure resistant and internal polymer coated aluminum containers.

1. The paper-based materials are the important part of pharmaceutical packaging.
2. Paper-based materials include: Labels, Cartons, Bags, Outers, Trays For Shrink Wraps, Layer Boards On Pallets, etc.
3. The Applications as well as Advantages of Cartons include:
   • Increases display area
   • Provides better stacking for display of stock items
   • Assembles leaflets
   • Provides physical protection especially to items like metal collapsible tubes.
4. Fiberboard outers either as solid or corrugated board also find substantial application for bulk shipments.
5. Regenerated cellulose film, trade names Cellophane & Rayophane, is used for either individual cartons or to assemble a no. of cartons.

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:

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

Uses of films, foils, laminations:

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

Safety

Performance