Pharmaceutical Packaging (PHARM 131) PDF

PHARM 131: PHARMACEUTICS 2 PACKAGING Professor, RPh | Reviewed: Nov. 19, 2024 | Last Edited: Nov. 19, 2024 ○ Revised Rules and Regulations Governi...

PHARM 131: PHARMACEUTICS 2 PACKAGING Professor, RPh | Reviewed: Nov. 19, 2024 | Last Edited: Nov. 19, 2024 ○ Revised Rules and Regulations Governing the Generic Labeling OUTLINE Requirements of Drug Products for Human Use PACKAGING TYPES OF PACKAGING SYSTEMS PACKAGING SYSTEMS Primary – has direct contact with the product during FUNCTIONS OF PACKAGING SYSTEMS storage and delivery TYPES OF PACKAGING SYSTEMS ○ E.g. bottles, cap (e.g. twist, flip-top caps), cap liner, CLASSIFICATION rubber stoppers, silica gel, cotton MATERIALS USED Silica gel - act as a dessicant GLASS Cotton - para di malaki yung head space (act like TYPE 1 HIGHLY RESISTANT BOROSILICATE a filler), and as a dessicant GLASS vials - the glass shard gets filtered out TYPE 2 TREATED SODA LIME GLASS TYPE 3 REGULAR SODA LIME GLASS TYPE 4 general purpose PLASTIC TYPES OF PLASTIC COMMON PLASTIC PACKAGING MATERIALS DRUG-PLASTIC CONSIDERATIONS METALS RUBBER PAPER FOIL, FILMS LAMINATES PROTECTION ABILITY QUANTITY HELD IDEAL REQUIREMENTS (6) SELECTION OF PACKAGING MATERIALS PACKAGING PACKAGING SYSTEMS Secondary – contains the primary pack and ancillary Packaging - all operations, including filling and labelling, components which a bulk product has to undergo in order to become a ○ Basically, yung nakahawak kay primary finished product ○ E.g. box packaging, metal cap on a vial, medicine dropper beside a serum FUNCTIONS OF PACKAGING SYSTEMS Packaging is the means of economically providing: ○ Containment ○ Protection ○ Identification & Information CLASSIFICATION ○ Convenience & Compliance Material Used ○ Presentation ○ Glass ○ Detection of counterfeiting ○ Plastic there are a lot of counterfeit in the market, one ○ Metal way to know the authentic product is through the ○ Paper packaging like their watermarks ○ Foil companies need to make a system to prevent ○ Films counterfeit products being mistaken as real ○ Laminates ○ Rubber AO No. 8 2016-0008 Protection Ability ○ Well-Closed TRANS TEAM MEMBERS 1 bit.ly/TransDatabase  ○ Tightly Closed TYPE 4 general purpose ○ Hermetic Least resistance to leaching chemical attack and heat ○ Light-Resistant shock Ex. Amber Bottle Non-parenteral glass Exposing it to sunlight may cause a RedOx Uses reaction ○ Oral solid and liquid dosage forms ○ Child-Resistant ○ External preparation ○ Tamper-Resistant Quantity Held PLASTIC ○ Single-Unit Consists of polymers of HMW with certain additives ○ Multiple Unit (plasticizers, antioxidant, lubricant, stabilizers) that can be molded into shape by heat and pressure MATERIALS USED Advantages GLASS ○ Durable Supercooled liquid formed after fusion of sand (silicon ○ Lightweight dioxide), sodium carbonate, and calcium carbonate ○ Low cost with the latter ingredients transformed to oxides at the Disadvantages: high temperatures used ○ Less resistant and inert Advantages: ○ Leaching of additives ○ Inert to most chemicals ○ Environmental concerns ○ Strong and rigid ○ provides excellent barrier TYPES OF PLASTIC Disadvantages ○ Fragile and heavy THERMOPLASTIC ○ High Cost ○ Can be softened and shaped multiple times with the ○ Releases alkali to aqueous preparations introduction of heat and mechanical force Can be reheated Types of Pharmaceutical Glasses ○ Flexible and squeezable ○ Type I - Highly resistant borosilicate glass THERMOSET ○ Type II - Treated Soda Lime Glass ○ Can be only shaped once and remain in a permanent ○ Type III - Regular Soda Lime Glass solid state once hardened ○ Type NP - General Purpose Soda Lime Glass ○ Reheating causes decomposition TYPE 1 HIGHLY RESISTANT BOROSILICATE GLASS COMMON PLASTIC PACKAGING MATERIALS Highest resistance to leaching, chemical attack and heat PET Bottles (polyethylene terephthalate) shock ○ Clarity, lightness, strength, Alkalinity is reduced by adding boron oxide (6-10%) toughness, barrier to liquid and Uses: gas ○ Buffered and non-buffered aqueous parenteral Not for pharmaceutical solutions use, for food and ○ Laboratory glass apparatus beverage ○ Used extensively for food/drink bottles (e.g. water, soft drink, juice, peanut butter/jam jars) TYPE 2 TREATED SODA LIME GLASS Moderate resistance to leaching, chemical attack and heat High-Density Polyethylene (HDPE) shock ○ Stiffness, strength, toughness, Surface is treated with SO2 resistance to moisture, permeability ○ Adds additional resistance to leaching, chemical to gas, ease of processing attack and heat shock but not as strong as Permeable to gas - hence borosilicate presence of cotton or silica gel to Use: absorb moisture ○ Neutral and acidic aqueous parenteral solutions ○ Solid DF containers, shampoo and detergent bottles, milk jars TYPE 3 REGULAR SODA LIME GLASS Hard bottle packaging in tablets Low resistance to leaching, chemical attack, and heat shock Polyvinyl Chloride (PVC) Commonly used in food packaging ○ Versatility, ease of blending Uses strength, toughness, clarity, ○ Non-aqueous preparations transparency ○ Reconstituted dry solids Clear and transparent - can ○ Large volumes see table content ○ Least resistance to permeation and rarely recycled TRANS TEAM MEMBERS 2 bit.ly/TransDatabase  ○ Blister packs (on top of the foil), cling wrap, pipe and Complexometric reactions - there are cancer fitting, synthetic leather drugs that can form complexes with metals e.g. aluminum; kaya cancer drugs have special Low-Density Polyethylene (LDPE) packaging ○ Flexibility, resistance to moisture, ease of sealing, ease of processing, RUBBER low melting point Mainly used for construction of seals (sa vials) ○ Grocery bags, squeeze bottle, Natural medicine droppers ○ Good resealing ○ Fragmentation Polypropylene (PP) ○ Coring properties ○ Excellent resistance to Synthetic heat, chemicals, grease and ○ Better resistance to moisture and gas permeation oil; strength toughness ○ Fewer additives barrier to moisture This is ideal as it promotes fewer potential ○ Microwaveable and interactions autoclavable containers, bottle caps PAPER Polystyrene (PS) Widely used for secondary and tertiary packaging ○ Versatility clarity insulation Matted or felted sheet usually composed of natural plant easily formed fibers ○ With hot and oil contents ○ Wax paper is used for paper tabs 2 PS could leach styrene that When the paper material weighs 250 𝑔/𝑚 or more or is is considered as brain and 300µm or more in thickness, it is known as paperboard NS toxicant Advantages ○ Styrofoam ○ Low cost, readily available ○ Easily printed DRUG-PLASTIC CONSIDERATIONS ○ Non-toxic design ○ Rigidity and strength Permeation Disadvantages ○ Transmission of gases vapor or liquid through plastic ○ No barrier properties packaging Madaling mabasa; some companies coat them in Leaching plastic material ○ Release of constituent from plastic container to drug product FOIL, FILMS LAMINATES From container to content Foils Sorption ○ Thin sheets of metal usually made of aluminum ○ Removal of constituents from the drug product to the Films container ○ Regenerated cellulose or cellophane Material of product dumidikit sa container Laminates Chemical Reactivity ○ Made by bonding together two or more layers of ○ Materials in plastic containers react chemically with different materials drug product Produces byproduct which can be harmful PROTECTION ABILITY Well closed METALS ○ Protects articles from contamination by extraneous Tinplate solids and liquids ○ Sheet of steel coated with tin on both sides Tightly closed ○ Cheap ○ Protects articles from contamination by extraneous Aluminum by solid, liquid, or vapors Light yet strong Hermetic Easier to shape ○ Impervious to air or any other gas Very inert Light resistant For high-grade pharmaceuticals ○ Packaging system that protects from the effects of Advantages light (290 to 450 nm) by virtue of the specific ○ Strong and rigid properties of the material of which it is composed, ○ Malleable including any coating applied to it. ○ Impermeable to gases Child-Resistant ○ Tamper-evident ○ Packaging that is difficult for a child young than 5 yrs Disadvantages old to open (or gain access to the contents in a ○ Expensive reasonable period but not difficult for an adult—up to ○ Potential interaction and including seventy years old—to use properly TRANS TEAM MEMBERS 3 bit.ly/TransDatabase  Strength Manual coordination Tamper-Resistant ○ May not be accessed without obvious destruction of the seal or some portion of the packaging system Shrink seal there is a need to tear it first before one can open it Breakable cap cap will break once it is twisted/rotated Tape seal tape is damaged upon opening hence cannot be returned Bottle seal usually for solid dosage forms Aerosol the most tamper-resistant among all seals QUANTITY HELD Single unit container ○ Designed to hold a quantity of drug product intended for administration as a single-dose or intended for use promptly after the container is opened Unit Dose Container - non-parenteral blister pack, strip packs, sachet Single-Dose - parenteral ampoules, single-dose vials Multiple unit container ○ Permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion Multiple Dose - parenteral multiple-dose vials, bottles aerosols IDEAL REQUIREMENTS (7) Compatible with the preparation Afford protection against external influences (light, gasses, moisture, temperature variations) and biological contamination that may alter the properties of the product during storage Possess sufficient strength to withstand shocks of handling/transportation Minimize loss of constituents due to leakage, spoilage, or permeation Facilitate easy and accurate identification of product Facilitate efficient, safe, and convenient administration of contents The cost of material should be as low as possible without compromising the quality SELECTION OF PACKAGING MATERIALS (7) Characteristics of components Dosage form Route and mode of administration Stability and compatibility Customer convenience Packaging method and facilities available Cost of the Product TRANS TEAM MEMBERS 4 bit.ly/TransDatabase