Packaging (Pharmaceutics)

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[Packaging]:

[Packaging] V V S Narayana Reddy Karri Lecturer Dept of Pharmaceutics JSS College of Pharmacy, Ootacamund ( JSS University, Mysore ) Rocklands Udhagamandalam.

Introduction:

Introduction After the manufacturing of pharmaceutical products they must stored properly. So they have been stored in containers Pharmaceutical container has been defined as a device that holds the drug and it may or may not be in direct contact with the pharmaceutical preparations. Closures are the devices by means of which containers can be opened and closed . 2

1. Containers:

1. Containers 3

Qualities of Good Container:

Qualities of Good Container It should be non-toxic It should not interact with medicament physically or chemically. It should withstand changes in pressure and temperature (sterilization of parenteral products with container and closures). It should withstand the wear and tear during normal handling. It should be designed in such a way that the dose can be drawn from it conveniently . Container must be neutral towards the material in which it is stored. It should maintain the stability of the product from the external environments which cause deterioration. 4

Types of Containers:

Types of Containers 1. Single dose containers Ampoules and vials 2. Multi dose containers Vials 3. Light resistant containers Amber colored bottles 4. Well closed containers Protects the loss of contents during transportation. 5. Air tight containers Protects the medicament from moist, air and dust 6. Tightly closed containers Protects the medicament from liquids, solids and vapors 7. Temper – evident containers Fitted with a mechanism that reveals irreversibility whether the container has been opened. 8. Aerosol Containers These containers are used to hold the aerosol products and they can withstand the pressure. 5

Materials used for Making of Containers:

Materials used for Making of Containers 6

Glass:

Glass 7

Glass:

Glass Advantages: Transparent Available in various shapes and sizes. Economical and readily available Can protect the photosensitive medicaments from light during storage Impermeable to moisture and atmospheric gases Easily labeled They can be sealed hermetically or by removal closures Disadvantages: Glass is fragile Glass containers are heavy , which increase the cost of its transportation Glass containers may release alkali to aqueous preparations 8

Composition of Glasses :

Composition of Glasses Composition: Sand, soda ash, lime stone and cullet Cullet is a broken glass that is mixed with the batch and acts as a fusion agent for the entire mixture. 9

Types of Glass:

Types of Glass Lime-soda glass: Manufacturing easy and inexpensive . Suitable for storage of solid medicaments but not liquid medicaments because it liberates chemicals. Borosilicate glass: It is chemically more inert than lime-soda glass. It is a highly resistant glass . Silicone treated glass: Glass treated silicone, so that it can be used to store alkali sensitive materials. Sulphured glass: It is a cheaper variety of glass used for construction of containers for parenteral products . It does not liberate alkali . Neutral glass: It will resistant to alkali and also withstand autoclaving . Amber color glass: Used to store photosensitive pharmaceutical products because it has capacity to filter U.V light. 10

Containers for parenteral preparations:

Containers for parenteral preparations Type I glass: Also called borosilicate or neutral glass. Offers high hydrolytic resistance. Type II glass: Also called soda-lime-silicate glass. Suitable for acidic and neutral aqueous preparations. Type III glass: Also called soda-lime-silicate glass with only moderate hydrolytic resistance. They are suitable for non-aqueous preparations for parenteral use such powders 11

Hydrolytic resistance glass test:

Hydrolytic resistance glass test 12

Plastics:

Plastics 13

Plastic materials:

Plastic materials MATERIAL ADVANTAGES DISADVANTAGES TYPICAL USES High density polyethylene (HDPE ) Inert, low cost, low water vapour transmission, tough. Semi-opaque, transfer of taste ingredients, absorb dilute solutions. Detergents, bleaches, milk, foods, cleansing powders, drugs & cosmetics. Low density polyethylene (LDPE ) Squeeze property, inertness, low cost. high water vapor transmission. Cosmetics, personal products, foods. Polyvinylchloride (PVC ) Clarity and stiffness difficult to process, susceptible to organic solvent. Shampoo, bath oil, detergent. Polymethyl methoacrylate (PMMA) Hard and strong Transparent Bottles and tubes Polystyrene Clarity, stiffness, and low cost. High water vapor transmission, susceptibility to cracking, poor impact. Dry drugs, petroleum jelly. Polypropylene Inert, low cost. brittleness Drugs, cosmetics, syrups, juices. Polyamide Tough , good O 2 -barrier, sterilizable . High cost, water absorption Foods, drugs, cosmetics, aerosols Polycarbonate Very tough, clear, sterilizable Cost, susceptibility to solvent cracking, poor barrier for water and O 2 . Drugs, cosmetics. 14

TYPE OF PLASTICS:

TYPE OF PLASTICS Plastics are classified into two groups according to their behavior when heated: 1. Thermoplastic type On heating, they soften to a viscous fluid which hardens again on cooling. e.g. Polyethylene, polypropylene, polyvinylchloride, polystyrene, nylon (polyamide), polycarbonate, acrylic multipolymers , polyethylene terephthalate etc. 2. Thermosetting type When heated, they may become flexible but they do not become liquid ; usually their shape is retained right up to the temperature of decomposition . Because of a high degree of cross-linking they are usually hard and brittle at room temperature. e.g. phenol-formaldehyde, urea formaldehyde, melamine formaldehyde 15

Metals:

Metals 16

Slide 17:

Advantages: Sturdy Impermeable to light, moisture and gases Light in weight compared to glass Disadvantages: They are expensive They may leak metal particles in to the medicament They react with certain drugs and chemicals 17

Different Metals:

Different Metals Aluminium , Tin and Lead are used for the construction of collapsible tubes. Collapsible tubes made from Aluminum is light in weight, less costly and used for tooth paste and creams . Collapsible tubes made from tin are most widely in industry because of high compatibility however, they are costly. Lead tubes are the cheapest tubes among all however, they will not be used in pharma industry because of lead poisoning . 18

Paper and Board:

Paper and Board They are used to prepare outer containers such as cartons, boxes, envelops and drums to provide additional mechanical support to the secondary packing's. drums boxes cartons 19

2. Closures:

2. Closures 20

Closures:

Closures Closures are the devices by means of which containers can be opened and closed . 21

Types of Closures:

Types of Closures 1. Plug type These types are push-fit into containers ex: cork or glass stopper 2. Crown cap Used as closure for beverages 3. Push-fit Simple slide fit over the neck of the container 4. Screw closures 22

Slide 23:

4. Screw closures Very commonly used. It consists of 3 components 1. Cap: Made of tin or aluminium usually, also made up with plastic. Plastic caps are better than metal caps because they capable of resisting corrosion and also do not contaminate the product. 2. Wad: It is a seal which prevents the contamination of product. It should be inert and should not absorb the product It is made up of rubber or silicon rubber 3. Liner: It is made up of metal foils , rubber, plastic films etc., 23

Materials used for making of closures:

Materials used for making of closures Cork Obtained from the bark of oak tree Chemically inert and not impart any odor or flavor to the product However, it is not used for many preparations because of mould growth These have been replaced with plastic and rubber closure nowadays Glass Glass closure are rarely used These are mainly used for reagent bottles in laboratories. Plastic Most commonly used Available in various shapes and sizes Light in weight and unbreakable They have to be tested for any extractable matter contained in it. Metal Commonly used Made of tin or aluminum Rubber Mainly used for the construction of closures meant for vials , transfusion bottles , etc., The natural rubber is obtained from heavea braziliensis , it will be processed with additives (activators, filters, accelerating agents, lubricants, pigments and softners ) to change it physical properties 24

Slide 25:

25

Ideal properties of rubber:

Ideal properties of rubber It should be soft It should quite elastic It should not absorb medicament It should withstand the temperature and pressure during autoclaving Impermeable to moisture and water Compatible with ingredients of pharmaceutical products. 26

Aerosol Packing:

Aerosol Packing 27

Aerosol:

Aerosol Aerosol may be defined as disperse phase system in which very fine solid particles or liquid droplets get dispersed in the gas (propellant) which acts as continuous phase . These are also called pressurised dosage forms 28

Advantages of Aerosol:

Advantages of Aerosol The medicament can be delivered directly to the affected area such as burnt skin and wound. Application of medicament is easier Absence of air prevents oxidation of the product. The hydrolysis of medicaments can be prevented. The sterility of the products can be maintained. Drugs can be given by oral inhalation . 29

Slide 30:

Aerosol are costly preparations. Some of the propellants are very toxic . The cooling effect of highly volatile propellants may cause discomfort on injured skin. Lot of difficulties are faced in aerosol formulation when the drug is not soluble in propellant. Disadvantage of Aerosol 30

Classification of aerosols:

Classification of aerosols Space spays: These are finely divided sprays having particle size up to 50 µ . Ex: Room deodorizers, Insecticides Surface coats: These are also sprays but disperse particles are coarse with sizes up to 200 µ . Ex: Hair spays, personal deodorant and topical medicament sprays. Foam: These are produced by rapid expansion of propellants through an emulsion. Ex: Shaving cream 31

Formulation of Aerosols:

Formulation of Aerosols It basically consists of a propellant and the medicaments to be propelled. Propellant: It develops a pressure in the container Compressed gases such as CO 2 , N 2 or liquefied gases like methane or ethane can be used as propellants. These days propellants like trichloro - fluoro -methane , dichloro - difluoro -methane etc., are used in pharmaceutical aerosols The medicaments to be propelled may be solid or liquid. It may be soluble in the propellent or insoluble in it. 32

Aerosol system Types:

Aerosol system Types Two Phase system ( Vapour + Propellant): This type of system employed when the medicament (solid or liquid) is soluble in the propellant or no other solvent required to dissolve the solid or liquid which using for formulation. Hence this aerosol system will have one liquid phase (Propellant) and gaseous phase is above it. Three phase system (Propellant + Vapour phase+ Water): It is employed in cases where the medicament (solid or liquid) is immiscible with the propellant. Hence the medicament (solid or liquid) is dissolved in a liquid (water) which does not mix with the liquefied propellant. 33

Containers used for aerosols:

Containers used for aerosols Container: Made of metal and plastic which can withstand high pressure. Valves: It will deliver the contents Continuous spray valve: Medicament is released continuously as long as the pressure is applied on the actuator. Metering valve: Definite amount is released. Foam valve: Releases the medicament in the form of foam . Actuator: It is fitted on the valve stem. It helps in opening and closing of valve. Dip tubes: It takes the liquid from the bottom of the container to the valve at the top. 34

Slide 35:

1. Cold-fill process This process is used to fill metered aerosol product using a fluorocarbon propellant. By lowering the temperature of a propellant below its boiling point the propellant becomes liquid at atmospheric pressure. The active ingredient or concentrate and propellant are cooled to a low temperature of -30 0 to-40 0 F . The concentrate is generally cooled to below 0 0 C in order to reduce loss of propellant during the filling operation. The chilled concentrate is poured into the chilled container The valve is fitted on to the container which is placed into a water bath so that the contents are heated to 130 0 F (54 0 C) in order to check any leakage and strength of container. A dry ice-acetone bath is used to obtain the desired low temperature for laboratory scale preparation whereas refrigeration equipment is used for the large scale production of aerosols Packaging of Aerosols 35

Slide 36:

2. Pressure-fill process:- This process is used for filling aerosols containing hydrocarbon propellant . The product concentrate is placed into the container and the valve is sealed. The propellant is forced through the valve under pressure . After this the container is immersed in a water bath at 130 0 F (or 54 0 C) in order to check any leakage and strength of the container. 36 Packaging of Aerosols

Slide 37:

They are used for spray bandages and for application of drugs meant for topical use . They are used for spray administration of drugs into various body cavities . They are used to spray cosmetic preparation such as perfumes . They are used to spray disinfectants, deodorizers and air sanitizers. Application of Aerosol Packaging 37

Modern “Unit Dose” Packing:

Modern “Unit Dose” Packing

Advantages:

Advantages Light weight Temper resistant Wastag e is reduced They are hygienic Child resistant Disadvantages Elderly patients may experience difficulty in use Expensive. 39

Types of unit dose packaging:

Types of unit dose packaging Blister package Strip package Bubble package Sachet package Oral liquid dispenser 40

Blister package:

Blister package Consist of lid and blister (transparent) The lid material usually aluminium foil . Blister is made of poly vinyl chloride, poly styrene, poly propylene or their combinations. Blister packing is formed by heat-softening and vacuum drawing the softened sheet of plastic in to a contoured mould. After cooling the sheet it is removed from the mould. The semi-rigid blister formed is filled with tablet or capsule and lidded . 41

Blister package…:

Blister package… Lid has to satisfy certain criteria: It should protect the pack material It acts barrier to moisture and atmospheric gases It must seal to the blister material and retain the medicament within the blister It should tear easily when blister content is pushed through it Blister should have the following qualities: It acts barrier to moisture and atmospheric gases It must soften without shrinking but stay soft without melting It should be flexible enough to allow removal of the contents. 42

Strip package:

Strip package Product pocket Films The material used for strip packing are cellophane, polyester, , polyethyelene , polypropylene 43

Bubble package:

Bubble package The bubble packing is done sandwiching the product between thermoformable , heat shrinkable plastic film and a rigid backing material. This is done by heat softening of the plastic film and withdrawal of vaccum from a packet in to the film in a similar manner as done in blister packing. 44

Sachet package:

Sachet package The sachet packs are invariably a laminated with alumium foil serving as the center core , besides a heat sealable plastic material as the product contact substance. Sachets are usually made using the following 3 steps: Formation of carrying pouch Dosing with requisite product Hermatically sealing process 45

Oral liquid dispenser:

Oral liquid dispenser It contains a plastic pot sealed with a laminate , the laminate is torn off before use. In a plastic syringe-type dispenser, the syringe is available in a number of sizes . The tip of the syringe is sealed by a small plastic ring . 46

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