UNIT -01 PACKAGING & LABELLING OF PHARMACEUTICALS

1. UNIT -01PACKAGING & LABELLING OF PHARMACEUTICALS N.SANTHI PRIYA ASSISTANT PROFESSOR DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

2. CONTENTS • Desirable features of a container • Types of container • Glass as container; Merits and demerits • Plastic as a container; Merits and demerits • Rubber as closure material ; Merits and demerits • Labelling requirements

3. Introduction: • Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, containment, convenience ,compliance , integrity and stability of the product. • The selection of a package therefore begins with a determination of the product’s physical and chemical characteristics, its protective needs, and its marketing requirements.

4. The materials selected must have following characteristics: • They must protect the preparation from environmental conditions. • They must not be reactive with the product. • They must not impart to the product tastes or odors. • Must be non toxic. • They must be “FDA” approved. • They must meet applicable tamper – resistance requirements. • They must be adaptable to commonly employed high-speed packaging equipment

5. TYPES OF PACKAGING : • Primary packaging : Primary packaging is the material that envelopes 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.

6. Secondary packaging • Is outside the primary packaging-perhaps used to group primary packages together.

7. Tertiary packages: • Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container.

8. Types of containers: Containers are divided into following types on the basis of their utility : • Well – closed containers: A well-closed container protects the contents from loss during transportation,handling,storage or sale. • Single dose containers: These containers are used to supply only one of medicament and hold generally parenteral products. E.g. ampoules and vials

9. Multi dose containers: These containers allow the withdrawal of dose at various intervals without changing the strength, quality or purity of remaining portion. these containers hold more than one dose and are used for injectables. E.g. vials • Light-resistant containers: These containers protect the medicament from harmful effects of light. These containers are used to store those medicaments which are photo-sensitive.

10. Air-tight containers: These are also called hermetic containers. These containers have air-tight sealing or closing. These containers protect the products from dust, moisture and air. Where as air-tight sealed containers are used for injectables,air-tight closed containers are meant for the storage of other products. • Aerosol containers: These containers are used to hold aerosol products. These containers have adequate mechanical strength in order to bear the pressure of aerosol packing.

11. CLASSIFICATION OF THE PACKAGING PRIMARY PACKAGING MATERIALS TERTIARY PACKAGING MATERIAL For Tablets Or Capsules Like Unit Dosage Forms Corrugated box Brown cardboard box Wood pallets Shrink wrap Blister Pack, Strip Pack, Glass Bottles, Plastic Bottles SECONDARY PACKAGING MATERILS For Liquid Preparations Vials, Ampuls, cartridges, glass Bottles, Plastic Bottles Paper and boards cartons For Powder Or Granules Foil, paper Or Plastic Pouch, Glass Or Plastic Bottles For Semisolid Preparations Collapsible Tubes For Suppositories Film Wrappers Containers For Aerosols

12. TYPES OF PACKAGING : • Primary packaging : Primary packaging is the material that envelopes 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.

13. Secondary packaging • Is outside the primary packaging-perhaps used to group primary packages together.

14. Tertiary packages: • Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container.

15. QUALITIES OF GOOD CONTAINER: • The container must be neutral towards the material which is stored in it. • The container must not interact physically or chemically with the substance which it holds. • It should help in maintaining the stability of product against the environmental factors which causes its deterioration. • It should be made of materials which can withstand wear and tear during normal handling. • It should be able to withstand changes in pressure and temperature. • The materials used for making of the container must be non-toxic.

16. MATERIALS USED FOR MAKING OF CONTAINERS: • GLASS- • e.g.bottles,vials,ampules,syringes,i.v containers, aerosol containers. • PLASTIC- • e.g.bottlespouches,tapes,tubes,aerosolcontainers,laminates.

17. RUBBER- • e.g. closures, caps,vialswrapers,plungers. • Metals- • e.g. collapsabletubes,foils,needles,aerosol containers

18. Paper or cardboard- e.g. secondary packaging labels,inserts,displayunits,pouches,laminates,cartons,carrogated boxes,foils,paper drums

19. GLASS CONTAINERS: • Composition of glass: • Glass is composed principally of sand, soda ash, lime stone and cullet. • Sand is almost pure sillica,soda ash is sodium carbonate, lime stone is calcium carbonate. • Cullet is broken glass that is mixed with the batch and acts as fusion agent for the entire mixture.

20. Manufacture of glass: The four basic processes used in the production of glass are:- Blowing uses compressed air to form the molten glass in the cavity of metal mold. In drawing, molten glass is pulled through dies or rollers that shape the soft glass. In pressing mechanical force is used to press the molten glass against the side of a mold. Casting uses gravity or centrifugal force to cause molten glass to form in the cavity of mold.

21. TYPES OF GLASSES: • Type I-borosilicate glass • It is highly resistant glass. • It has high melting point so can with stand high temperatures. • It is more chemically inert than the soda lime glass. • It can resist strong acids,alkalies and all types of solvents. • Reduced leaching action. • USES: • Laboratory glass apparatus. • For injection and water for injection.

22. Type II-treated soda lime glass • Type II containers are made of commercial soda lime glass that has been dealkalised or • treated to remove surface alkali. • The de-alkalizing process is know as sulfur treatment. • Sulfur treatment neutralizes the alkaline oxides on the surface, rendering the glass more chemically resistant. • Uses: • Used for alkali sensitive products. • Infusion fluids, blood and plasma. • Large volume container.

23. Type-III regular soda lime glass • Containers are untreated are made of commercial soda lime glass of average are better than average chemical resistance. • It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances. • Flakes separate easily. • USES: • For all solid dosage forms. • For oily injections.

24. Type NP-general purpose soda lime glass • Containers are made of soda lime glass supplied for non parental products, intended for oral or topical use. USES: FOR ORAL USE. TOPICAL PURPOSE.

25. ADVANTAGES OF GLASS: • They are quite strong and rigid. • They are transparent which allows visual inspection of the contents. • They are available in various shapes and sizes. • They can withstand the variation in temperature and pressure during sterilization. • They are economical and readily available. • They can protect the photosensitive medicaments from light during their storage. • They do not deteriorate with age.

26. DISADVANTAGESOF GLASS: • They are brittle and break easily. • They may crack when subject to sudden changes in temperatures. • They are heavier in comparison to plastic containers.

27. PLASTIC CONTAINERS: • Plastics are synthetic polymers of high molecular weight. • Plastics as packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality and the freedom to design. • Plastic containers are extremely resistant to breakage and offer safety consumers.

28. PLASTIC ARE OF TWO FROMS: • Amorphous plastic. • Crystalline plastic. • AMORPHOUS PLASTIC: • They give good transparency. • They are hard but posses little brittleness. • They are more permeable to gases and vapour. • They are of less inert.

29. CRYSTALLINE PLASTICS: • For photo sensitive drugs this type of plastics are selected. • They are opaque. • They are more flexible. • They are less permeable to gases and vapour. • They are more inert.

30. PLASTIC: • Plastics are synthetic polymers of high molecular weight. • Plastics as packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality and the freedom to design. • Plastic containers are extremely resistant to breakage and offer safety consumers

31. ADVANTAGES OF PLASTIC: • They are light in weight and can be handled easily. • They are transported easily. • They are unbreakable. • They available in various shapes and sizes. • They are resistant to inorganic chemicals.

32. TYPES OF PLASTIC: Thermoplastic type :- On heating, they are soften to viscous fluid which hardens again on cooling. e.g. polyethylene ,PVC ,Polystyrene ,polypropylene ,Polyamide ,Polycarbonate. Thermosetting type :- When heated , they may become flexible but they do not become liquid. Phenol formaldehyde ,urea formaldehyde, melamine formaldehyde

33. BASED ON UTILITY OF PLASTIC: • Rigid materials. • Flexible materials. • Metallic surfaces. • Plastic cements. • Special case plastic.

34. RIGID MATERIALS: • These are phenolic resins with resins various inert filler. • Used in fabrication of number of items. • Light in weight. • Used in gears, pipes ,fittings, ducts, valves, vessels. • Resistant to corrosion except oxidizing substance and strong alkali.

35. FLEXIBLE MATERIALS: • These are thermo plastic materials. • These materials can be rigid or flexible depending upon the amount of plasticizer added. • They are used in fabrication of tanks, pipes , funnel, buckets.

36. METALLIC SURFACE: • Plastics of polyethylene or polyvinyl chloride types are used along with plasticizer for the coating of metallic surfaces. • These are used to protect the metal from corrosion. • These linings are applied on tanks, vessels ,stirrer and fans.

37. PLASTIC CEMENTS: • Used for spaces between acid resistant tiles and bricks. • SPECIAL CASE: • Plastics are used as guards for moving parts of machinery. • Nylon and PVC fibers woven into filters cloth and are used • for aseptic screening.

38. Plastic containers for pharmaceutical products are primarily made from the following polymers: • polyethylene • polypropylene • poly vinyl chloride • polystyrene • polymethyl methacrylate • amino formaldehyde • poly amides

39. TYPES OF PLASTICS: Thermoplastic type :- On heating, they are soften to viscous fluid which hardens again on cooling. e.g. polyethylene ,PVC ,Polystyrene, polypropylene, Polyamide, Polycarbonate. Thermosetting type :- When heated , they may become flexible but they do not become liquid. Phenol formaldehyde ,urea formaldehyde, melamine formaldehyde

40. Polyethylene: • Its is flexible, very light but tough plastic. • It is impermeable to water vapour and does not deteriorate with age unless it is exposed to sunlight for long time. • It has permeability to certain oils and preservatives. • Its melting point being in the range of 1100 to 1500c • It has high melting point and can sterilized by autoclaving. • It is divided into 1. HDPE (HIGH DENSITY POLYETHYLENE ) • 2. LDPE ( LOW DENSITY POLYETHYLENE ) • HDPE : Inert, low cost, tough in nature. • LDPE : Inert, great resistant to gases, low cost.

41. POLYVINYL CHLORIDE (PVC ): • It is less flexible , heavier and more permeable to water vapour as • compared with normal polythene.it has high clarity and not effected • by sunlight. It is used for preparing eye ointment tubes.

42. POLYMETYL METOCARYLATE(PMMA): • It is hard , strong but light, transparent plastic. • It softens at about1000c. • It is used for preparing bottles and tubes.

43. POLYSTYRENE: • It is a hard, rigid , light material. • It can be easily molded into any shape. • So it is used for preparing bottles, tubes,jars,boxes and syringes.

44. POLYCARBONATE: • It is transparent, has high impact strength and very good heat resistance. • It is used in the preparation of surgical equipment.

45. ADVANTAGES OF PLASTIC: • They are light in weight and can be handled easily. • They are transported easily. • They are unbreakable. • They available in various shapes and sizes. • They are resistant to inorganic chemicals.

46. DISAVANTAGES OF PLASTIC: • They are permeable to water vapour and atmospheric gases. • They are poor conductor to heat. • They may absorb chemical substances, such as preservative for solutions. • They are relatively expensive.

47. DRUG-PLASTIC CONSIDERATIONS A packaging system must protect the drug without altering the composition of the product until the last dose is removed. Drug-plastic considerations have been divided into five categories: Permeation Leaching Sorption Chemical reaction Alteration

48. Permeation: It is the transmission of gases, vapors or liquids through plastic packaging material. Permeation of water vapor and oxygen through plastic wall into the drug is a major problem is the dosage form is sensitive to hydrolysis and oxidation. The volatile ingredients might change when stored in plastic containers and the taste of the medicinal products may change for the same reason of permeation.

49. Leaching: Some plastic containers have one or more ingredients added to stabilize it, these may leach into the drug product. Problems may arise with plastics when coloring agents are added in small quantities to the formula. Particular dyes may migrate into the parental solution and cause a toxic effect.

50. Sorption: This process involves the removable of constituents from the drug product by the packaging material. The therapeutic efficacy of the product may be reduced due to sorption. Sorption may change the chemical structure, Ph., solvent system, concentration of active ingredients and temperature etc…