“PACKAGING OF PHARMACEUTICni¢ 2.1 PACKAGING MATERIALS i das assortment of diverse components whic ; me Dera veduetsaroundings, from the manufacturing to till its ste ‘d for naa vital component in the various drug developments in healthcare fits e Leen re is one of the important factors for stability of drug during stora ” ean te quality of products during storage, transportation, delivery and sale, BE. To packaging is essential. The effective packaging plays important role to transform the formulation into an attractive and marketable product. 2.2 TYPES OF PACKAGING MATERIAL The packaging materials are classified into three types: 1. Primary packaging material: * Consists packaging components have direct contact with the product, «Main role to protect or preserve the contents from chemical, climatic, and biological hazards. * Examples are: ampoules, vials, 2. Secondary packaging material: * External packaging to primary packaging is called secondary packaging. * Offers the supplementary physical protection, needed at the time of warehousing and refill packaging. * Examples include cartoons, paper and boards 3. Tertiary packaging material: * It is most commonly employed to protect the product and primary and secondary packaging as well. * Used for bulk handling, shipping and warehouse storage of the product. * Examples include barrel, container, edge protectors 2.3 SELECTION CRITERIA OF PACKAGING MATERIAL * Must be approved by food and drug administration (FDA) "Should be non-toxic : Should be neutral towards the material which is stored in it. Should not change the odor and taste of the product. | Scanned with CamSc:2.4 FACTORS AFFECTING THE CHOICE OF PACKAGING MATERIAL = The market » The product » The distribution system + Manufacturing facilities 2.5 FUNCTIONS OF PACKAGING = Clear identification of product «= Loading and transportation + Proper storage = Protective function «Containment = Convenience 2.6 MATERIALS USED FOR PACKAGING There are four main packaging materials which are described below, used for pharmaceutical packaging. 1. Glass: This is very commonly used in pharmaceutical packaging due to its excellent protective nature. Advantages: There are several advantages of glass used as packaging material "Economical = Easy to clean, strong and rigid * Does not deteriorate with age * Chemically inert = Withstand with different temperatures and pressures * Impermeable to moisture and atmospheric gases «Easily labeled «Available in different sizes and shapes = Transparent * Non-reactive * Can protect photosensitive drugs from light during storage Disadvantages: "More transportation cost due to its weight «Fragile, easily broken if dropped "May release alkali to preparation containing water. Scanned with CamSc:~a It consist sand, soda ash, lime stone and cullet. The broke, the soda ash is sodium carbonate a Bass ig Composition of gla md calcium known as cullet. The sand is mostly silica, carbonate is lime stone. Cullet is normally act as fusion agent. Types of Glass 1. Type-t (Borosilicate glass): Consist SiO2 (80%), Bz03(12%), Alz03(6%), small quantity of Naso, Chemically more inert than soda lime glass . Cag, + Highly resistant Has superior melting point, able to withstand with high temperay ‘ature and pressure. * Laboratory glass apparatus, Borosil, Pyrex 2. Type-Il (Treated soda lime glass) + More inert then borosilicate glass. «Treatment is done to remove the alkali from glass surface = Dealkanization is done by treatment with sulfur. = Sulfur neutralizes the alkaline oxide from the glass surface and makes glass more chemically resistant. * Used for blood and plasma products, alkali sensitive products. 3, Type-III (Regular soda lime glass) = Isnot suitable for alkali sensitive product. * Not expensive * Consist SiO2(75%), NazO (15%), CaO (10%) = Mainly stored solid medicaments = Average chemical resistance 4. Type-IV (General purpose soda lime glass): * Generally used to prepare containers to supply non parenteral products used * Has least hydraulic resistance * Suitable for solid, liquid and semi-solid, oral and topical preparations. 5. Amber colored glass: * Used to store photosensitive pharmaceutical preparations * Has capacity to filter out ultra-violet rays ical 2. Plastic: The second most common packaging material employed for pharmaco preparation is plastic, 5 follows: Classification of plastic: Plastic is classified into two groups which are a * Thermoplastic type: Scanned with CamSe¥ Gets softened into viscous fluid on heating and again hardens on cooling. Y The degree of cross linking between long chain molecules is the reason for hardness. y Examples include nylon, polymethyl methaacrylate, PVC, polystyrene, Polypropylene * Thermosetting type This type of plastic become flexible on heating but does not become fluid. Y Generally hard and brittle at room temperature due to high degree of cross linking. Y Urea formaldehyde resins, Melamine formaldehyde, phenol formaldehyde resins. i Advantages: "Cheap in price : * Unbreakable and leak proof : «Light in weight so less transportation cost = Available in different size and shapes * Ge od protection power = Resistant to inorganic chemicals * Have adequate mechanical strength * Poor heat conductor "Suck back feature Disadvantages: Permeable to water vapor and atmospheric gases. "Stress cracking «Paneling or cavitation = Cannot stand against high temperature "May absorb chemicals, like preservatives from product. * May interact with some ingredients cause softening or distortion. Composition of plastic: 1. Polyethylene: * Isalso called polythene, having high density «Flexible, very light but tough in nature = Does not deteriorate with age Impermeable to water vapor but poor permeability towards oxygen and environmental gases. Scanned with CamSc:eat es int 110°C TO 115°C «Melting po’ 1158 «Used for autoclave sterilization inges” an » Used to prepare sy" products. 2, Polypropylene: = Similar to = Very light and resistal © Melting point 170°C * Suitable for boilable packages «Noteworthy resistance against acids and alkalis = Autoclave sterilization is possible * Used to prepare disposable syringes, 3. Poly methyl methacrylate (PMMA): = Hard, tough, light and transparent = Softens around 100°C = Used to prepare tubes and bottles 4, Polyvinyl chloride (pvc) «Heavy, flexible, inexpensive = More permeability to water vapor as compared to polythene «= Transparent and barrier towards oxygen = Melting point is 160°C «Very poor heat stability "Not affected by sunlight * Used to prepare eye ointment tubes * Not affected by acids and alkalis, oxidizing acids are exceptional + Itstarts to degrade at 280°C, should not be overheated. 5. Polystyrene: * Crystal clear plastic, non-biodegradable * Hard, rigid light in weight * Made from petroleum High water vapor transmission and gaseous permeability Used to . : area Prepare bottles, tubes, jars, syringes and boxes. d containers to store pharmay é ig high density polythene nt to heat tubings, squeeze bottle etc, Also known as nylons Made when diami : ‘ine combined with dibasic acid Very tough plastic . " Ge ‘0od amount of flexibility with heat resistance Ocalineu Wit Gals= Autoclaved easily = Difficult to destroy by mechanical means «Has electro negative polar centers, attract preservatives such as phenol, parahydroxybenzoic acid «Used to prepare syringes, tubing, surgical dressings = Examples of FDA approved nylons are: Nylon 6, Nylon 6/6, Nylon 6/10, Nylon 11 7. Polycarbonate: Expensive and transparent = Can be sterilized repeatedly * Good resistance against heat = Resistant to dilute acids and oxidizing or reducing agents «Used to prepare surgical equipment 3. Metal: These are commonly used to manufacture containers for bulk packaging of tablets, capsules, powders. The commonly used metals are aluminium, tin, lead, tin Pit steel and stainless steel. Tin are mostly preferred to store food, pharmaceuticals and other products where purity is important. * Aluminium is preferred because of their light weight and offer elegant appearance. = Lead is cheap amongst all the metals and mostly used for non-food products such as paints, lubricants, inks and adhesives. Advantages: * Sturdy or strong in nature * Impermeable to gases, moisture and light * Labels can be easily and directly printed on surface of metal " Have good resistance against chemical attack "Used for the preparation of collapsible tubes "Metal foil used to wrap suppositories or pessaries Disadvantages: * Expensive "May release particles into the pharmaceutical formulation * Not employed for extemporaneous dispensing of product 4. Rubber: " It is most widely used in pharmaceutical industry to fabricate closures, cap liners. * The rubber stopper is used for multiple dose vials and disposable syringes. Scanned with CamSc:Qi Q2 Q3 Q4 Qs Q6 * Most widely used rubbers are natural, butyl rubber, neoprene, chloroprene rubber. Advantages: + Permeability towards water vapor = Slow water absorption + Cheaper i «Nitrile rubber are heat resistant due to polar nitrile group = Chloroprene rubber is oil resistant Disadvantages: = Silicone rubbers are expensive * Slow decomposition happens of butyl rubber above 130°C = Absorption of bactericide and extractive leaching happens with nitrile rubber “nitrile NUbbe, , Define packaging. Refer 2.1 Classify types of packaging material used for packaging of pharmaceuticals. Refer 2.2 Write the composition of Type-I (Borosilicate glass). Refer 2.6 (a) SiO2 (90%), BrOs(1%), Al03(96%) (©) SiO, (8%), B:0s(2%), Al05(96%), (6) SiOz (80%), BrOs(12%), AhO3(6%), (4) $102 (15%), Bs0x(98%), Alz0x(96%), What is the melting point of polyethylene. Refer 2.6 (a) 110°C TO 115°C (b) 115°C TO 125°C (©) 1458C TO 1550C : (4) 180°C TO 190°C Define cullet. Refer 2.6 What is the full form of PMMA. (@) Polyethylene methyl methacrylate () Plastic methylene methacrylate (©) Poly metho methacrylate (a) Poly methyl methacrylate Plastic which gets softened into viscous fluid on heating and again hardens on cooling called The melting point of PVC is-——----—-, my wee maial is preferred because of their light weight and offer ‘~~ is defined as assortment of diverse components which utilized for pharmaceutical prod surroundings, from the. manufacturing to till its utilization. Js oeenee Mi th ive nat sS very commonly used in pharmaceutical packaging due to its excellent protectv® Scanned with CamSc:Q3c Q4a Qs Q6d Q7 Thermoplastic Q8 160°C Q.9 Aluminum Q.10 Packaging Q.11 Glass Differentiate thermoplastic and thermosetting plastic. Refer 2.6 Classify plastic as packaging material. Refer 2.6 Q3 Write about type II glass. Refer 2.6 Q4 Classify functions of packaging. Refer 2.5 Name the factors which affect the choice of pharmaceutical packaging material. Refer 2.4 QJ Describe types of packaging material. Refer 2.2 Q2_ Write advantages, disadvantages and types of glass in detail. Refer 2.6 Q3_ Write a note on pharmaceutical packaging material. Refer 2.1 to 2.6 Q4 Explain metal as pharmaceutical packaging material. Refer 2.6 Q5 Briefly describe plastic as pharmaceutical packaging material. Refer 2.6 Scanned with CamSc: