packaging of pharmacutical products

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08/03/13 AMIT KUMAR SHRIVASTAVA B.PHARM 1 Kailash Institute of Pharmacy and Management Gorakhpur

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08/03/13 DEEPAK SHARMA 2 CONTENTS : PACKAGING FUNCTIONS OF PACKAGING TYPES OF PACKAGING COMPONENTS OF PACKAGING AEROSOL PACKAGING CONTAINER & CLOSURES PACKAGE TESTING REFERENCES

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08/03/13 3 PACKAGING Packaging has been defined as the means economically providing :- Presentation Identification Protection Convenience Containment during storage

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. Primary' or 'Sales' packaging is packaging which forms a sales unit for the user or final consumer, for example, a box containing soap powder 'Secondary' or 'Grouped' packaging is that which contains a number of sales units, for example, a cardboard outer containing a number of boxes of soap powder. 'Tertiary' or 'Transport' packaging is packaging that is used to group secondary packaging together to aid handling and transportation and prevent damage to the products 4/2/2013 PRASHANT SINGH 4 PACKAGING

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4/2/2013 PRASHANT SINGH 5

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DEEPAK SHARMA 6 TYPES OF PACKAGING: SOLID PRODUCTS 2. SEMI-SOLID PRODUCT LIQUID PRODUCTS UNIT PACKS CHILD RESISTANCE PACKAGING 6. TEMPER RESISTANCE PACKAGING

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08/03/13 DEEPAK SHARMA 7 1. SOLID PRODUCTS: Solid dosages form such as tablets and capsules are by far the most commonly used today. Traditionally they have been packed in bottles, originally made from glass but latterly from various plastics. The walls of the container are usually amber or completely opaque to minimize the possibility of photo degradation. Powder or granules have a variety of role when used as a final dosage form. They usually packed as single dosages in flexible sachets.

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08/03/13 DEEPAK SHARMA 8 2. SEMI-SOLID PRODUCT 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. Semi solid product include creams, emulsions, g els or ointments. Flexible tubes are frequently used to contain semi solids. These can be made from aluminium or plastic such as polyethylene.

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9 3. LIQUID PRODUCTS Traditionally 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 .

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10 UNIT PACKS: Unit packs in which individual dosage are separated from each other are popular for many type of dosage form.

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11 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

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12 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.

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13 COMPONENTS OF PACKAGING: GLASS METALS RUBBERS PLASTICS FIBROUS MATERIALS FOIL, FILMS &LAMINATES

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14 GLASS: Glass is composed of sand, soda ash, limestone,& cullet. Si, Al, B, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass ADVANTAGE: They are transparent. They have good protection power. They can be easily labelled . DISADVANTAGE: Glass is fragile so easily broken. Release alkali to aqueous prerparation .

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4/2/2013 PRASHANT SINGH 15 TYPE OF GLASS: COLOURED GLASS OR AMBER GLASS SULPHURED GLASS BOROSILICATE GLASS TREATED SODALIME GLASS REGULAR SODALIME GLASS GENERAL PURPOSE SODALIME GLASS

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4/2/2013 PRASHANT SINGH 16 Type of glass Main Constituents Properties Uses Type-1 Borosilicate glass e.g. Pyrex, Borosil SiO 2  80 % B 2 O 3  12 Al 2 O 3 - 2% Na 2 O+CaO - 6% Has high melting point so can withstand high temperature Resistant to chemical substances Reduced leaching action Laboratory glass apparatus For injections and for water for injection . Type-II Treated soda-lime glass Made of soda lime glass. The surface of which is treated with acidic gas like SO 2 (i.e. dealkalised ) at elevated temperature (500 0 C) and moisture. The surface of the glass is fairly resistant to attack by water for a period of time. Sulfur treatment neutralizes the alkaline oxides on the surface, thereby rendering the glass more chemically resistant. Used for alkali sensitive products Infusion fluids, blood & plasma . large volume container Type-III Regular -soda-lime glass SiO 2 Na 2 O CaO It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances Flakes separate easily. May crack due to sudden change of temperature. For all solid dosage forms (e.g. tablets, powders ) For oily injections Not to be used for aqueous injection Not to be used for alkali-sensitive drugs . Type NP Non-parenteral glass or General purpose soda-lime glass. For oral and Topical purpose Not for ampoules. Colored glass/ Amber Glass Glass + iron oxide Produce amber colour glass Can resist radiation For photosensitive products.

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17 PLASTICS: These are synthetic polymers of high molecular weight. These containers are made from following polymers : POLYETHYLENE POLYVINYL CHLORIDE POLYSTYRENE NYLON POLYCARBONATE

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

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19 RUBBERS: Rubbers are excellent material for 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 These are consist of Two types: NATURAL SYNTHETIC

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20 FIBROUS MATERIALS: Paper & board are used in various form for packaging of pharmaceutical products. They are used for preparing outer container such as cartons, boxes, envelopes.

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21 FOIL, FILMS & LAMINATES FOILS: The most important metal for this application is aluminium. FILMS Cellophane is an attractive transparent film which can be coloured 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.

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22 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: Absence of air prevents oxidation of the product The application of medicaments is easier DISADVANTAGE: Aerosols are costly preparation Some of the propellants are very toxic

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23 PARTS OF AEROSOL CONTAINER The Propellant : Propellants are those materials which expel the contents of the container through valves by applying force. The Product concentrate (active ingredients & agents such as solvents, antioxidants & surfactants) The container of aerosol The valves & actuators

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4/2/2013 PRASHANT SINGH 24 1. Liquefied Gases 2. Compressed Gases i . Chlorofluorocarbon (CFC) a. Trichloromonofluoromethane or Propellant 11 b. Dichlorodifluoromethane or Propellant 12 c. Dichlorotetrafluoroethane or Propellant 114 Properties: Are non-polar compounds. Are miscible with non-polar solvents at different temperature. Are immiscible with water. Co-solvents like ethanol; 2-propanol is added to make it miscible. In metered dose inhalers, only ethyl alcohol can be used as co-solvent. Are chemically inert. Are non-flammable. Are non-toxic in nature. i . Carbon dioxide (CO 2 ) ii. Nitrous oxide (N 2 O) iii. Nitrogen (N 2 ) Properties: Are non-polar compounds. Are chemically inert. Are non-flammable. Are non-toxic in nature. Used in dental creams, hair preparation, ointment & antiseptics. Used for semi-solid products. ii. Hydrocarbons iii. Hydrofluorocarbons The Propellant

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4/2/2013 PRASHANT SINGH 25 1. METAL a. Tin-Plated Steel: It is used because:- They are light in weight. They are inexpensive. Helps in large scale production. Are available as thin sheets. Provide sufficient protect to certain product without any treatment on the inner side of the container. If additional protection is required, then container is coated with organic materials i.e. Oleo resin & phenolic material. b. Aluminium: It is used because:- Produced by an impact extrusion process in order to obtain a container which is seamless . Most of the metered dose inhalers & aerosols are made up of aluminium. Withstand at high pressures. Compatible & less reactive in nature. More resistant to corrosion. If additional protection is required, then container is coated with organic materials i.e. Polyamide or phenolic resins, vinyl, epoxy material. The Product concentrate

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4/2/2013 PRASHANT SINGH 26 2. GLASS Glass are used in the formulation of aerosols containers because:- Are compatible with many substances. Products which have low pressure and products which have propellants in low % formulated in GLASS containers. They are more stronger than metallic container. Various designs of glass containers are available. Provide greater resistance to corrosion. 2 types of glass containers are used for AEROSOL products. a. Plastic-coated Glass These containers help in preventing the glass from breaking into small pieces at the time of breakage. These containers are used in formulation of topical & MDI’s aerosols. b. Uncoated Glass Their cost is low & they provide more clarity by which all the contents of the containers can viewed.

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28 CONTAINER AND CLOSURE CONTAINER: 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. TYPES OF CONTAINERS WELL CLOSED CONTAINER SINGLE DOSE CONTAINER MULTI DOSE CONTAINER LIGHT RESISTANCE CONTAINER AIR TIGHT CONTAINER AEROSOL CONTAINER

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29 CLOSURE: An effective closure must prevent the contents from escaping & allow no substance to the container. TYPE OF CLOSURE: PLUG TYPE CROWN TYPE PUSH FIT TYPE SCREW TYPE

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30 COMMON TYPE OF PACKAGING BLISTER PACKAGING 2. STRIP PACKAGING 3. BUBBLE PACKAGING

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32 PACKAGE TESTING These are divided into Two groups:- TESTING MATERIALS TESTING PACKAGES CHEMICAL MECHANICAL ENVIRONMENTAL ENVIRONMENTAL MECHANICAL

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33 REFERENCES : A ulton Michael E., “ Aulton’s Pharmaceutics The Design and Manufacture of Medicines”, Edited by Churchill Livingstone Elsevier limited, 3 rd edition,2007,pp 626-639. 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. Cooper and Gunn’s, “Tutorial pharmacy”, edited by S.J.Carter,Publishing by CBS publisher &distributors, Delhi, 6 th edition, 2005,pp 131-141. Mehta R.M., “Pharmaceutics- 1”Published by vallabh prakashan, delhi, 2 nd edition, pp 73-93. http://www.ipapharma.org/events/Stability/JBhat.pdf

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