The materials selected for packaging 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

PCU-511

Pharmaceutics-V (Dispensing Pharmacy)

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.

PCU-511

Pharmaceutics-V (Dispensing Pharmacy)

USES OF PACKAGING: Physical protection: It protects from, among other things, mechanical shock, vibration, electrostatic discharge, compression, temperature, etc. Information transmission: Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and chemical products, some types of information are required by governments. Marketing: The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. Convenience: Packages can have features that add convenience in distribution, handling, stacking, display, sale, opening, re-closing, use, dispensing, reuse, recycling, and ease of disposal. Barrier protection: A barrier from oxygen, water vapor, dust, etc., is often required. Permeation is a critical factor in design. Some packages contain desiccants or oxygen absorbency to help extend shelf life. Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary function. Security: Packaging can play an important role in reducing the security risks of shipment. Packages can be made with improved tamper resistance to deter tampering PCU-511 to help Pharmaceutics-V and also can have tamper-evident features indicate tampering.
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TYPES OF PACKAGING Primary packaging is the material that first envelops 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. Examples: Ampoules,Vials ,Containers ,Dosing dropper ,Closures (plastic, metal) ,Syringe ,Strip package. Secondary packaging is outside the primary packaging perhaps used to group primary packages together. Example: Paper and boards, Cartons Tertiary packaging is used for bulk handling , warehouse storage and transport shipping.

PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

DESIRABLE FEATURES OF CONTAINERS AND CLOSURES:

1.Rigidity: the container must be rigid enough to prevent damage to the contents e.g. fracture of tablets and crushing of capsules; 2.Material of construction: The material of construction must not react with the contents; 3. The closure must prevent--Access of moisture, e.g. moisture sensitive tablets and capsules as heir shells are hygroscopic Loss of moisture from creams and from water containing ointments and pastes Unintentional escape of the contents
PCU-511 Pharmaceutics-V (Dispensing Pharmacy) ---Continue-----

d. Entry of dirt and any other contaminants such as odorous vapours that might cause tainting (tainting means Spotted or stained) 4. The closure must easily be removed and replaced. 5. It must not be difficult to withdraw the contents or to empty the container completely. 6. For light sensitive products, protection from light must be given Medicaments or adjuncts must not be absorbed by the container materials nor must diffusion through the walls be possible. 7. It must be easy to label the container correctly. 8. It must have a pharmaceutically elegant appearance.
PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

TYPES OF CONTAINERS:

With respect to method of closure, the B.P.C. defines four types of container1.Air Tight Container: Protects from contamination by extraneous solids, liquids and vapors and, under ordinary conditions of handling, storage & transport, prevent changes due to efflorescence, deliquescence and evaporation. 2.Securely-closed: This is an airtight container with a means of preventing unintentional displacement of the closure. 3.Hermetically-sealed: This container is impervious to air and other gases under normal conditions of handling, storage and transport. The most common example is a glass ampoule sealed by fusion. 4.Well closed Container: Protects from extraneous solids & loss of article under ordinary or customary PCU-511 conditions of handling, shipment, storage & Pharmaceutics-V
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transport, prevents unintentional release of the contents.

CLASSIFICATION OF CONTAINERS ON THE BASIS OF CLASSES OF PREPARATION FOR WHICH THEY ARE SUITABLE: 1. Liquid Oral Preparation

a. Intended to be swallowed b. Not Intended to be swallowed 2. Other Liquid Preparations a. For Application to the skin or use in body cavities b. For Inhalation 3. Semi-solid Preparations for Application to the Skin or Mucosa a. Collapsible Metal or Plastic Tubes b. Glass or Plastic Pots 4. Solid Unit-dose Preparations a. Intended to be swallowed or sucked b. Intended for use in body cavities 5. Powders a. For Oral Administration b. For use Externally Or in Body cavities
PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

MATERIALS USED FOR MAKING OF CONTAINERS: 1. GLASS: e.g. bottles, vials, ampoules, syringes, i.v containers, aerosol 2. PLASTIC: e.g. bottles pouches, tapes, tubes, aerosol containers. 3. RUBBER: e.g. closures, caps, vials wrappers. 4. METALS e.g. collapsible tubes, foils, needles, aerosol containers

PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

TYPES OF GLASSES:

1. 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.
PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

2.Type II (treated soda lime) glass

Type II containers are made of commercial soda lime glass that has been de-alkalised 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.
PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

3. 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. USES: For all solid dosage forms. For oily injections.

PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

4. Type IV (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.

PCU-511 Pharmaceutics-V (Dispensing Pharmacy)

CLOSURES Closures are the devices by means of which containers can be opened and closed. Proper closing of the container is necessary because It prevents loss of material by spilling or volatilization. It avoids contamination of the product from dirt, microorganisms or insects. It prevents deterioration of the product from the effect of the environment such as moisture, oxygen or carbon dioxide. Material used for closures are: The closures for containers meant for storage of pharmaceutical products are generally made from the following basic materials. Cork Glass Plastic Metal Rubber
PCU-511 Pharmaceutics-V (Dispensing Pharmacy)