Pharmaceutical Packaging PDF

Pharmaceutical Packaging 1 7/15/2013  PACKAGING Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of...

Pharmaceutical Packaging 1 7/15/2013  PACKAGING Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging may also be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use. 2 7/15/2013  CHARACTERISTICS OF PACKAGING MATERIAL: The material selected must have the following characteristics: Must meet tamper-resistance requirements Must be FDA approved Must be non-toxic Must not impart odor/taste to the product Must not reactive with the product They must protect the preparation from environmental conditions 3 7/15/2013  USES OF PACKAGING: Physical protection: It protects from, among other things, mechanical shock, vibration, electrostatic discharge, compression, temperature, etc. Information transmission: Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and chemical products, some types of information are required by governments. Marketing: The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. Convenience: Packages can have features that add convenience in distribution, handling, stacking, display, sale, opening, re-closing, use, dispensing, reuse, recycling, and ease of disposal. 4 7/15/2013  Barrier protection: A barrier from oxygen, water vapor, dust, etc., is often required. Permeation is a critical factor in design. Some packages contain desiccants or oxygen absorbency to help extend shelf life. Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary function. Security: Packaging can play an important role in reducing the security risks of shipment. Packages can be made with improved tamper resistance to deter tampering and also can have tamper-evident features to help indicate tampering. Packages can be engineered to help reduce the risks of package pilferage. 5 7/15/2013  TYPES OF PACKAGING Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Examples: Ampoules,Vials ,Containers ,Dosing dropper ,Closures (plastic, metal) ,Syringe ,Strip package, Blister packaging. 6 7/15/2013 Secondary packaging is outside the primary packaging – perhaps used to group primary packages together. Example: Paper and boards, Cartons ,Corrugated fibers ,Box manufacture) 7 7/15/2013 Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers. 8 7/15/2013 TYPES OF PACKAGING MATERIAL I) Glass II) Metals III) Rubbers IV) Plastics V) Fibrous material VI) Films, Foils and laminates 9 7/15/2013  GLASS:  Glass has been widely used as a drug packaging material.  Glass is composed of sand, soda ash, limestone,& cullet.  Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass Advantages They are hygienic and suitable for sterilization They are relatively non reactive ( depending on the grade chosen) It can accept a variety of closures They can be used on high speed packaging lines They are transparent. They have good protection power. They can be easily labeled. DISADVANTAGES It is relatively heavy Glass is fragile so easily broken. Release alkali to aqueous preparation 10 7/15/2013 TYPES OF GLASS: 1) Type I ( Neutral or Borosilicate Glass) 2) Type II ( Treated Soda lime glass) 3) Type III ( Soda lime glass) 4) Type IV ( General purpose soda lime glass) TYPE I GLASS  Least reactive.  Higher ingredients and processing cost therefore used for more sensitive pharmaceutical products such as parenteral or blood products.  Mostly ampoules and vials are made up of Type I glass. 11 7/15/2013 TYPE I I GLASS  Higher chemical resistance but not as much as type I.  Cheaper than Type I.  Acceptable for most products accept blood products and aqueous pharmaceutical with a pH less than 7. TYPE I I I AND TYPE IV GLASS Type II and Type III glass  Have similar composition and are distinguished from each other on the basis of their hydraulic resistance  Type III has average or slight better than average resistance and is suitable for non- aqueous parenterals and non parenteral products. Type III glass containers are normally dry sterilized before being filled.  Type IV has lowest hydraulic resistance and is suitable for solid products, some liquids and semi solids and not for parenteral. 12 7/15/2013  MINIMUM TYPE OF QUALITY OF PACKAGE TYPE FORMULATION GLASS THAT CAN CAN BE PACKED BE USED Aqueous Injectables Of Any Type I pH Ampoule Aqueous Injectables Of pH Type II Less Than 7 Non-Aqueous Injectables Type III Aqueous Injectables Of Any Type I pH Aqueous Injectables Of pH Type II Less Than 7 Vial Non-Aqueous Injectables Type III Dry Powders For Parenteral Use (Need To Be Type IV Reconstituted Before Use) 13 7/15/2013  MINIMUM TYPE OF QUALITY OF PACKAGE TYPE FORMULATION GLASS THAT CAN CAN BE PACKED BE USED Tablets, Capsules, Oral Solids & Other Solids For Type IV Reconstitution Oral Liquids (Solutions, Type IV Suspensions, Emulsions) Bottles and Nasal & Ear Drops Type IV Jars Certain Types Of External Type IV Semisolids (Rubeficients, Local Irritants) Blood & Related Products Type I Auxiliary Packaging Device Dropper With Certain Kind Of Products Type IV Aerosol product ( solution, suspension, emulsion or Aerosol container semisolid Type I type) 14 7/15/2013  METALS  Metal containers are used solely for medicinal products for non-parenteral administration.  Metal is strong, opaque, impermeable to moisture, gases, odors, light, bacteria, and shatterproof, it is the ideal packaging material for pressurized containers.  It is resistant to high and low temperatures  They include tubes, packs made from foil or blisters, cans, and aerosol and gas cylinders.  Aluminium and stainless steel are the metals of choice for both primary and secondary packaging for medicinal products.  Form an excellent tamper evident containers. ALUMINIUM It is relatively light yet strong Barrier to light and chemicals Impermeable and easy to work into a variety of formats, depending on its thickness. 15 7/15/2013  Thickest aluminium is used for rigid containers such as aerosol cans and tubes for effervescent tablets. Intermediate thickness are when mechanical integrity is still important but the pack should be capable of being reformed under a reasonable force. e.g. Collapsible tubes for semi solid preparations or roll on screw caps. Thinnest aluminium is used in flexible foil that are usually a component of laminated packaging material. Disadvantages and their overcome solution Major disadvantage is its reactivity in raw state, although it rapidly forms a protective film of aluminium oxide it is still liable to corrosion ( when exposed to some liquids and semi solid formulations, particularly at extreme pH or if the product contains electrolytes. To overcome this problem, Aluminium is lined with epoxide, vinyl or phenolic resins. They are work hardening like collapsible tubes are made by impact extrusion which tends to make aluminium less flexible. To overcome, flexibility has to restored by an annealing stage. 16 7/15/2013  RUBBERS (Elastomers): Excellent material for forming seals, used to form closures such as bungs for vials or in similar applications such as gaskets in aerosol cans. Categories of Rubbers: 1) Natural rubbers; Suitable for multiple use closures for injectable products as rubber reseals after multiple insertion of needle. Disadvantages are; i. It doesn't well tolerate multiple autoclaving becoming brittle and leads to relative degree of extractable material in presence of additives. ii. Risk of product absorbing on or in to a rubber. iii. It has certain degree of moisture & gas permeation. 2) Synthetic rubber: Have fewer additives and thus fewer extractable and tends to experience less sorption of product ingredients. Are less suitable for repeated insertions of needle because they tend to fragment or core pushing small particles of the rubber in to the product. E.g. Silicone, butyl, bromobutyl, chlorobutyl etc. Silicone is least reactive but it does experience permeability to moisture and gas. Softer rubbers experience less coring and reseal better, harder rubbers are easier to process on high speed packaging lines. 17 7/15/2013  PLASTICS According to British standards institutes plastics represents; ―A wide range of solid composite materials which are largely organic, usually based upon synthetic resins or upon modified polymers of natural origin and possessing appreciable mechanical strength. At a suitable stage in their manufacturing, most plastics can be cast, molded or polymerized directly into shape‖. Classes of plastics: There are two classes of plastics, reflecting the behavior with respect to individual or repeated exposure to heating and cooling.  Thermoplastics Capable of being shaped after initial heating and solidifying by cooling. Resistant to breakage and cheap to produce and providing the right plastics are chosen will provide the necessary protection of the product in an attractive containers. E.g. Polystyrene, polyethylene and polyvinyl chloride.  Thermosets They need heat for processing into a permanent shape. During heating such materials form permanent crosslinks between the linear chains, resulting in solidification and loss of plastic flow. E.g. Phenolic, urea and melamine are representative of thermosets. 18 7/15/2013 Uses Used for many types of pack including; rigid bottles for tablets and capsules, squeezable bottles for eye drops and nasal sprays, jars, flexible tubes and strip and blister packs. Advantages Least expensive than glasses Ease of transportation No risk of breakage Flexible Light in weight D i s a d va n t a g es They are not as chemically inert as Type -I glass. They are not as impermeable to gas and vapour as glass. They may possess an electrostatic charge which will attract particles. 19 7/15/2013  TYPES OFPLASTICS POLYETHYLENE  This is used as high and low density polyethylene  Low density polyethylene (LDPE) is preferred plastic for squeeze bottles. Properties: Ease of processing , barrier to moisture, strength /toughness, flexibility, ease of sealing.  High density poly ethylene (HDPE) is less permeable to gases and more resistant to oils, chemicals and solvents. Properties: Stiffness, strength / toughness, resistance to chemicals. It is widely used in bottles for solid dosage forms.  Drawback: prone to stress cracking in the presence of surfactants or vegetable or mineral oils. POLYPROPYLENE  It has good resistance to cracking when flexed.  Good resistance to heat sterilization.  It is colorless, odorless thermoplastic material with excellent tensile properties even at high temperature.  Excellent resistance to strong acids and alkalis.  Low permeability to water vapour  Permeability to gases is intermediate between polyethylene HD and un-plasticized PVC  Suitable for use in closures , tablet containers and intravenous bottles. 20 7/15/2013 POLYSTYRENE  Versatility, insulation, clarity, easily foamed (―Styrofoam‖).  It is also used for jars for ointments and creams with low water content.  Drawback: Chemicals like isopropyl myristate produce crazing(a fine network of surface cracks) followed by weakening and eventually collapsible of the container. POLYVINYL CHLORIDE  Versatility , ease of blending, strength / toughness, resistance to grease/oil, resistance to chemicals, clarity.  Used as rigid packaging material and main component of intravenous bags.  Drawback: Poor impact resistance which can be improved by adding elastomers to the plastics but it will increase its permeability. POLY VINYLEDENE CHLORIDE: Excellent barrier properties against: moisture, water vapour, UV light, aroma, inorganic acids, alkalies, aqueous salt solutions, organic water soluble acids, aliphatic hydrocarbons , esters of long chain fatty acids, detergent base materials, emulsifying agents and wetting agents. Good thermoform ability. PVDC is very cost-effective, as coating weight can be customized depending on the requirements of the barrier properties. Medical grade and non-toxic. High levels of transparency which improves the aesthetics of the product. 21 7/15/2013  EXAMPLES OF PLASTICS Plastic bottles made from PP, HDPE and Plastic pouches of HDPE Bottle- PET and spray- PP PS 22 7/15/2013 FIBROUS MATERIALS  The fibrous materials are the important part of pharmaceutical packaging.  Fibrous materials include: Papers, Labels, Cartons, Bags, Outers, Trays For Shrink Wraps, Layer Boards On Pallets, etc.  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.  Fiberboard outers either as solid or corrugated board also find substantial application for bulk shipments.  Regenerated cellulose film, trade names Cellophane & Rayophane, is used for either individual cartons or to assemble a no. of cartons. Paper Corrugated Fiber board 23 7/15/2013 FILMS, FOILS & LAMINATES 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. Foil blisters: When sealed with a metal foil-cover, the blister can provide a hermetic pack i.e. an isolated system, which excludes any exchange of gases between the product & surrounding atmosphere. 24 7/15/2013 Alu-alu foil is the best Pharmaceutical packaging film for tablets, capsules, which is taking place of PVC film. Characteristics: ◦ Applicable to tablets, capsules, pills, etc. ◦ It's a good substitute for PVC sheet. ◦ No cracking, delamination or pinholes ◦ It has the quite good blocking properties effectively protecting drugs from water vapor, oxygen and ultraviolet. ◦ It can extend the storage period of drugs. ◦ It is particularly suitable for packing moisture-sensitive drugs or those sold in the hot and humid areas. ◦ Taking out a part of the drugs from the drug boards without any impact on other well-packaged drugs. ◦ It is used by cold-moulding packaging machines. ◦ It is shaped easily by changing the mold. ◦ Nice appearance can upgrade drug's image 25 7/15/2013 CLOSURES Closures are the devices by means of which containers can be opened and closed. Proper closing of the container is necessary because ◦ It prevents loss of material by spilling or volatilization. ◦ It avoids contamination of the product from dirt, microorganisms or insects. ◦ It prevents deterioration of the product from the effect of the environment such as moisture , oxygen or carbon dioxide. Material used for closures are; The closures for containers meant for storage of pharmaceutical products are generally made from the following basic materials. ◦ Cork ◦ Glass ◦ Plastic ◦ Metal ◦ Rubber 26 7/15/2013  SYMBOLS USED ON PACKAGES AND LABELS Many types of symbols for package labeling are nationally and internationally standardized. For product certifications, trademarks, proof of purchase, etc. identification code. Fragile This way up Keep away from sunlight Keep away from water 27 7/15/2013