Pharmaceutical Packaging: Glass Types

Material Used for Manufacture of Containers

• The main types are glass, plastic, metal, and rubber.

Glass Packaging

• There are four categories of glass used in pharmaceutical packaging.
• Types I, II, and III are for parenteral products.
• Type IV is for non-parenteral products.
• Each type undergoes testing for water attack resistance.
• The degree of water attack is determined by the amount of alkali released under specific conditions.
• Alkali leaching can alter pH and product stability.
• Type I glass is the most resistant.

Constitution and Description of Official Glass Types

• Type 1: Highly resistant borosilicate glass, uses include buffered and unbuffered aqueous solutions, and powders.
• Type 2: Treated soda lime glass, uses include buffered aqueous solutions with a pH below 7, and dry powders.
• Type 3: Soda lime glass, uses include dry powders and oleaginous solutions, but not for aqueous preparations.
• Type 4: General purpose soda lime glass, not for parenterals, uses include suspension and emulsion.

Plastic Packaging

• Most products are now packaged in plastic, including intravenous fluids, ointment tubes, film-protected suppositories, and tablet/capsule vials.
• Widespread use is due to lightness, impact resistance, versatile design, consumer acceptance, and popularity of blister packs and unit-dose dispensing.
• Physical and chemical alterations of packaging material are called modification.
• Example: polyethylene modified to polypropylene or polyvinyl chloride (PVC).
• PVC is rigid and clear, making it useful for blister packs for tablets and capsules, but is unsuitable for gamma sterilization of medical devices.
• Newer plastics include polyethylene terephthalate (PET), amorphous polyethylene terephthalate glycol (APET), and polyethylene terephthalate glycol (PETG); APET and PETG have excellent transparency and can be sterilized with gamma radiation.

Problems with Plastic Packaging

• Permeability to oxygen and moisture
• Leaching of container components into contents
• Absorption of drugs by the container
• Transmission of light
• Alteration during storage
• Agents like plasticizers, stabilizers, antioxidants, antifungal agents, and colorants can alter plastic properties.
• Activity can decrease due to active substance adsorption.
• Active ingredient degradation can occur due to released substances.
• Content precipitation, pH change, appearance change, analytical interference, and safety changes can occur due to leaching.
• Permeability depends on polymer nature, amounts/types of additives, pressure, and temperature.
• Increased temperature/pressure/additives increase permeability.
• Glass containers are less permeable than plastic.
• Many products liable to deteriorate in humidity unless protected by high-barrier packaging, or use of a desiccant.
• Oxidative degradation may be greater in plastic.
• Liquid may lose drug molecules/solvent to the container, altering concentration and potency.

Leaching

• Describes movement of container components to contents.
• Compounds include polymer additives like plasticizers, stabilizers, or antioxidants.
• Occurs with liquids/semisolids in plastic, but less with tablets/capsules.
• Influenced by temperature, agitation, and solubilizing effect of liquid contents on polymers.

Sorption

• Indicates binding of molecules to polymer via adsorption and absorption.
• Occurs through chemical or physical means, with active agents or excipients.
• May be initiated by solute adsorption to the container's inner surface, then diffusion and binding within the plastic.
• Materials with polar groups are prone to sorption, depending on penetration/diffusion of a solute.
• Unionized solutes have greater tendency to bound than ionized species.
• pH influences sorption.
• Sorption of excipients can alter product quality.
• Methylparaben may be sorbed, reducing preservative concentration.
• Deformations, softening, hardening, and other changes can result from container contents or external factors, including temperature changes and physical stress.

Pharmaceuticals Labeling

• All drugs must meet labeling requirements: investigational drugs, prescriptions, controlled substances, OTC products, animal products, and medical devices.
• In addition, drug product insert include company literature and important information for health professionals.

Manufacturer's Product Label

• Usually affixed to the container.
• Includes the nonproprietary name (generic name).
• Includes name of the manufacturer or distributor.
• Includes quantitative statement of amount per unit.
• Includes pharmaceutical dosage form.
• Includes net amount of drug product in package.
• Includes "Rx only" logo or federal legend.
• Includes a reference to package insert.
• Includes special storage instructions.
• Includes National Drug Code and bar code.
• Includes lot or control number and expiration date.
• May include "Warning-May be habit forming”.

Prescription Label

• Includes pharmacy name/address, serial number, date of filling/refilling, prescriber name, patient name, and directions.

Additional Information on Prescription Label

• State laws may require inclusion of; patient address, dispensing pharmacist initials/name, pharmacy phone number, drug name/strength, drug manufacturer lot/control number, drug expiration date, and manufacturer/distributor name.

Considerations for Labeling

• In effort to decrease medication errors, considering including “indication” on the prescription label
• For over-the-counter (OTC) products should also include name, the manufacturer/distributor address, the quantity of net contents, the bar code and other product-identifying items, the expiration date, and the other drug-specific required information.

Proprietary Vs Non-Proprietary Drug Names

• Proprietary: A drug that has a trade name and is protected by a patent, synonyms: brand-name drug.
• Non-proprietary: Generic version of the active ingredient.

Dietary Supplement Labeling

• The labeling of a dietary supplement provides information on the product and includes; A vitamin/mineral/herb/amino acid substances.

Storage Conditions for Pharmaceutical Products

• Products must be stored with appropriate storage considerations and must include storage conditions, includes items such as temperature control.
• Cold: Not exceeding 8°C, typically inside a refrigerator maintained between 2° and 8°C.
• Freezer: A freezer is a cold place in which the temperature is maintained thermostatically between -25° and -10°C.
• Cool: Is generally between 8° and 15°C,
• Room temperature: Is ranged 20°C to 25°C. (but also allows for temperature variations between 15°C and 30°C.);
• Warm: Is generally between 30° and 40°C;
• Excessive heat: Is above 40°C;
• Protection from Freezing: Protects products from freezer burn and subjects products to the risk of container breakage, loss of strength or potency, or to destructive alteration of dosage form;
• Transportation: Transportation to and within geographic areas of extreme temperatures and humidity requires special consideration.