PACKAGING OF PHARMACEUTICAL PRODUCTS Dr J Domenech 1

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PACKAGING OF PHARMACEUTICAL PRODUCTS Dr. J. Domenech 1 4/5/2011

PACKAGING OF PHARMACEUTICAL PRODUCTS Dr. J. Domenech 1 4/5/2011

CONTENTS: q q q q 2 PACKAGING FUNCTIONS OF PACKAGING TYPES OF PACKAGING COMPONENTS

CONTENTS: q q q q 2 PACKAGING FUNCTIONS OF PACKAGING TYPES OF PACKAGING COMPONENTS OF PACKAGING AEROSOL PACKAGING CONTAINER & CLOSURES PACKAGE TESTING REFERENCES 4/5/2011

PACKAGING Packaging has been defined as the means economically providing : - • Presentation

PACKAGING Packaging has been defined as the means economically providing : - • Presentation • Identification • Protection • Convenience • Containment during storage 3 4/5/2011

TYPES OF PACKAGING: 1. SOLID PRODUCTS 2. SEMI-SOLID PRODUCT 3. LIQUID PRODUCTS 4. UNIT

TYPES OF PACKAGING: 1. SOLID PRODUCTS 2. SEMI-SOLID PRODUCT 3. LIQUID PRODUCTS 4. UNIT PACKS 5. CHILD RESISTANCE PACKAGING 6. 4 TEMPER RESISTANCE PACKAGING 4/5/2011

1. SOLID PRODUCTS: Ø Solid dosages form such as tablets and capsules are by

1. SOLID PRODUCTS: Ø Solid dosages form such as tablets and capsules are by far the most commonly used today. Ø Traditionally they have been packed in bottles, originally made from glass but latterly from various plastics. Ø The walls of the container are usually amber or completely opaque to minimize the possibility of photo degradation. Ø Powder or granules have a variety of role when used as a final dosage form. Ø They usually packed as single dosages in flexible sachets. 5 4/5/2011

2. SEMI-SOLID PRODUCT Ø The relevant characteristics of these products for packaging purpose are

2. SEMI-SOLID PRODUCT Ø The relevant characteristics of these products for packaging purpose are that they are often too viscous to flow but contain a sufficient amount of water to be classified as “wet ” products. ØSemi solid product include creams, emulsions, gels or ointments. ØFlexible tubes are frequently used to contain semi solids. ØThese can be made from aluminium or plastic such as polyethylene. 6 4/5/2011

3. LIQUID PRODUCTS ØTraditionally glass has been the material of choice for the packaging

3. LIQUID PRODUCTS ØTraditionally glass has been the material of choice for the packaging of liquid but a variety of plastics is now widely used providing they have little or no permeability to the liquid 7 4/5/2011

UNIT PACKS: ØUnit packs in which individual dosage are separated from each other are

UNIT PACKS: ØUnit packs in which individual dosage are separated from each other are popular for many type of dosage form. 8 4/5/2011

CHILD RESISTANCE PACKAGING: Child resistance container work on one of two principle§Certain degree of

CHILD RESISTANCE PACKAGING: Child resistance container work on one of two principle§Certain degree of strength will be needed to open the product. §High degree of manual coordination is required 9 4/5/2011

TAMPER RESISTANCE PACKAGING: Tamper resistance can be conferred on a pack by using a

TAMPER RESISTANCE PACKAGING: Tamper resistance can be conferred on a pack by using a roll on closure which has a perforated collar Which grips on to a lip on the bottle neck & these perforation must be broken before the cap can be unscrewed. 10 4/5/2011

q. COMPONENTS OF PACKAGING: I. GLASS II. METALS III. RUBBERS IV. PLASTICS V. FIBROUS

q. COMPONENTS OF PACKAGING: I. GLASS II. METALS III. RUBBERS IV. PLASTICS V. FIBROUS MATERIALS VI. FOIL, FILMS &LAMINATES 11 4/5/2011

I. GLASS: üGlass is composed of sand, soda ash, limestone, & cullet. üSi, Al,

I. GLASS: üGlass is composed of sand, soda ash, limestone, & cullet. üSi, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass q ADVANTAGE: § They are transparent. § They have good protection power. § They can be easily labelled. q. DISADVANTAGE: § Glass is fragile so easily broken. § Release alkali to aqueous prerparation. 12 4/5/2011

q TYPE OF GLASS: I. COLOURED GLASS OR AMBER GLASS II. SULPHURED GLASS III.

q TYPE OF GLASS: I. COLOURED GLASS OR AMBER GLASS II. SULPHURED GLASS III. BOROSILICATE GLASS IV. TREATED SODALIME GLASS V. REGULAR SODALIME GLASS VI. GENERAL PURPOSE SODALIME GLASS 13 4/5/2011

PLASTICS: üThese are synthetic polymers of high molecular weight. üThese containers are made from

PLASTICS: üThese are synthetic polymers of high molecular weight. üThese containers are made from following polymers : a) POLYETHYLENE b) POLYVINYL CHLORIDE c) POLYSTYRENE d) NYLON e) POLYCARBONATE 14 4/5/2011

METALS: v The thickest aluminium is used for rigid containers. Eg. Aerosol cans v

METALS: v The thickest aluminium is used for rigid containers. Eg. Aerosol cans v Intermediate thickness is steel important but the pack should be capable of being deformed under a reasonable force. Eg. Collapsible tube for semisolid preparations. v Thinnest aluminium is used in flexible foils. 15 4/5/2011

RUBBERS: ü Rubbers are excellent material forming seals so they are used almost exclusively

RUBBERS: ü Rubbers are excellent material forming seals so they are used almost exclusively to form closures such as bungs for vials or in similar application such as gasket in aerosol can üThese are consist of Two types: a) NATURAL b) SYNTHETIC 16 4/5/2011

FIBROUS MATERIALS: Ø Paper & board are used in various form for packaging of

FIBROUS MATERIALS: Ø Paper & board are used in various form for packaging of pharmaceutical products. ØThey are used for preparing outer container such as cartons, boxes, envelopes. 17 4/5/2011

FOIL, FILMS & LAMINATES FOILS: The most important metal for this application is aluminium.

FOIL, FILMS & LAMINATES FOILS: The most important metal for this application is aluminium. FILMS Cellophane is an attractive transparent film which can be colored and printed upon so it useful as outer wrap. LAMINATES Laminates are used to combine the properties of individual foil and films and strictly are made by bonding the layer with adhesive. 18 4/5/2011

q. AEROSOL PACKGING Aerosol may be defined as disperse phase system in which very

q. AEROSOL PACKGING Aerosol may be defined as disperse phase system in which very fine solid particles or liquid droplets get dispersed in the gas which act as continuous phase. §ADVANTAGE: üAbsence of air prevents oxidation of the product üThe application of medicaments is easier §DISADVANTAGE: üAerosols are costly preparation üSome of the propellants are very toxic 19 4/5/2011

PARTS OF AEROSOL CONTAINER II. VALVE III. ACTUATOR IV. DIP TUBE 20 4/5/2011

PARTS OF AEROSOL CONTAINER II. VALVE III. ACTUATOR IV. DIP TUBE 20 4/5/2011

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§ CONTAINER AND CLOSURE §CONTAINER: ü Pharmaceutical containers has been defined as a device

§ CONTAINER AND CLOSURE §CONTAINER: ü Pharmaceutical containers has been defined as a device that holds the drugs or it may or may not be indirect contact with the pharmaceutical preparation. v. TYPES OF CONTAINERS I. III. IV. V. VI. 22 WELL CLOSED CONTAINER SINGLE DOSE CONTAINER MULTI DOSE CONTAINER LIGHT RESISTANCE CONTAINER AIR TIGHT CONTAINER AEROSOL CONTAINER 4/5/2011

§CLOSURE: An effective closure must prevent the contents from escaping & allow no substance

§CLOSURE: An effective closure must prevent the contents from escaping & allow no substance to the container. § TYPE OF CLOSURE: A. B. C. D. 23 PLUG TYPE CROWN TYPE PUSH FIT TYPE SCREW TYPE 4/5/2011

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q. COMMON TYPE OF PACKAGING 1) BLISTER PACKAGING 2) STRIP PACKAGING 3) BUBBLE PACKAGING

q. COMMON TYPE OF PACKAGING 1) BLISTER PACKAGING 2) STRIP PACKAGING 3) BUBBLE PACKAGING 25 4/5/2011

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q REFERENCES: I. Aulton Michael E. , “Aulton’s Pharmaceutics The Design and Manufacture of

q REFERENCES: I. Aulton Michael E. , “Aulton’s Pharmaceutics The Design and Manufacture of Medicines”, Edited by Churchill Livingstone Elsevier limited, 3 rd edition, 2007, pp 626 -639. II. Lachman leon, Lieberman Herbert A. , Kanig Joseph L. , “The theory & practice of industrial pharmacy” published by Varghese publishing house, bombay, 3 rd edition, 1991, pp 711 -732. III. Cooper and Gunn’s, “Tutorial pharmacy”, edited by S. J. Carter, Publishing by CBS publisher &distributors, Delhi, 6 th edition, 2005, pp 131 -141. IV. Mehta R. M. , “Pharmaceutics- 1”Published by vallabh prakashan, delhi, 2 nd edition, pp 73 -93. V. http: //www. ipapharma. org/events/Stability/JBhat. pdf (15/11/09) 27 4/5/2011

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QUERIES? ? ? ? ? 29 4/5/2011

QUERIES? ? ? ? ? 29 4/5/2011