- Container for parenteral preparation should be
- Maintain the product as a sterile, pyrogen-free, high purity till it is used.
- Allow the withdrawal of the contents.
- Be strong enough to withstand processing and shipping.
- Not interact with the product.
Parenteral/injectable preparations are packaged into containers made of glass or plastic. Container systems include or Various type of parenteral containers:-
- Ampoules
- Vials
- Syringes
- Cartridges
- Bottles
For parenteral preparation/products, Glass is the preferred choice for containers. Glass container may either sealed (pull & tip seal) or closed with rubber stopper/closure.
Glass container
- Glass is composed of Silicon dioxide & a varying amount of oxides Na, K, Ca, Mg, Al, Boron etc.
- Basic structure network silicon dioxide tetrahedron.
- Baric oxide easily enters into the network structure of silicon dioxide & bound tightly & does not leach into the solution of the container. But other oxides do not enter into the network structure of silicon dioxide & loosely bound (other oxides), hence Relatively free to migrate which result in leached into solution in the glass Container, especially during the thermal Sterilization process. The leached oxide may hydrolyze & finally result in Raise pH & may catalyze or enter into the undesired reaction.
Glass containers are classified on the basis of hydrolytic resistance
- Type I/Borosillicate
- Type II/Sodalime treated
- Type III/Sodalime glass
- Type IV/NP
Type I/Borosilicate
- Also, know as Neutral Glass
- Composition – 81% – silicon dioxide; 13% – Boric oxide; other oxide (Na & Al etc) – non network forming oxide.
- Type Glass – Chemically inert – glass have high hydrolytic resistance due to the presence of Boric oxide & a high melting point due to silicon dioxide.
- Used for all types of preparation whether parenteral preparation or not & for all acid & Alkaline preparation or whether buffered or not.
Type II/Sodalime treated glass
- Composed of silicon dioxide & high proportional of Sodium oxide ( 14%) & Calcium oxide ( 18%).
- Also high hydrolytic resistance.
- Treated with SO2 & other dealkalizers to neutralize interior surface of the container [under controlled temp & humidity] to increases chemically resistance of glass.
- Also known as Sodalime treated glass
- Used for Acidic & Neutral or pH<7 buffered preparation
Type III/Sodalime glass
- moderate hydrolytic resistance
- Used for Non Aqueous Parenteral & powdered for injection preparation.
Type IV/NP glass
- Not used for parenteral preparation.
- Used for Oral use dosage form.
Container of Type-II & Type-III glass should be used once only
Siliconization: The application of a thin film of silicone to coat the inside surface of the vials and ampoules has been employed to prevent interaction of the product with the glass surface. The process also minimizes adsorption of active ingredients from homogeneous solutions, prevents adsorption of solids from suspensions and prevents aggregation at the glass surface in colloidal preparations.
Powdered Glass Test & Water Attack Test
Types of Glass is determined from two tests:-
- Powdered Glass Test
- Water Attack Test
| Powdered Glass Test | Water Attack Test |
|---|---|
| Applicable to Glass Type I, III, & IV | Applicable to Glass Type II only |
| Challenge leaching potential of inner/interior surface of a glass container | Challenge only intact surface of a glass container |
| Performed on a part of the container | Performed on the whole container |
Hydrolytic resistance test for Glass container
| Type of container | Test to be done |
|---|---|
| Type I and II to distinguish from Type III | Type I (surface test) |
| Type I and Type II have high hydrolytic resistance is due to chemical or treatment | A test I and II both |
Plastics containers
- For sterile preparations, such as large-volume parenterals, ophthalmic solutions, and, increasingly, small- volume parenteral, Thermoplastic polymers have been used as packaging materials for containers.
- Plastics used for parenteral products are mainly composed of polyethylene or polypropylene. Among these, polypropylene containers can withstand sterilization by autoclaving (Due to high m.p. of 165 degree centigrade.
- Plastic containers are mainly popular for intravenous fluids.
- Some other ingredients are added to plastic materials for special purpose like plasticizers, fillers, antistatic, antioxidants etc.
Polypropylene
- Polyprolene has high M.P. of 165 degree centigrade (so withstand autoclave for sterilization).
- It has high tensile strengh
- It has relatively low permeability to gases and vapors as compare to other plastic.
- It has translucent in appearance.
- Flexible polypropylene– used for ophthalmic product (Drops).
Note:
- Flexible polyvinyl chloride- used for bags for I.V. infusions.
- Polyolefine- Used for rigid bottles (to hold particular shape.)
Advantages of using plastic packaging materials
- they are not breakable, as is glass.
- less weight as compare to glass so less transport cost
- flexiblility: bags of polyvinyl chloride or select polyolefins.
Disadvantages of using plastic packaging materials
- not being as clear as glass
- soften or melt under the conditions of thermal sterilization
There are three major problems occurs in using plastic materials:
- Permeation of vapors and other molecules in either direction through the wall of the plastic container
- Leaching of constituents from the plastic into the product
- Sorption (absorption and/or adsorption) of drug molecules or ions on the plastic material.
Closures for Parenteral Preparation: Rubber
Closures (Pharmaceutical closures, also known as stoppers or bungs) that form part of the container-closure system. Container-closure system are an important component in the packaging of sterile products.
Container-closures maintain the sterility of parenteral pharmaceuticals and prevent contamination when a needle is inserted into a vial.
The most commonly used type of stopper is the elastomeric closure/Rubber closure.
The elastomer is either natural rubber or synthetic rubber, such as butyl rubber or chlorobutyl rubber. The advantage of synthetic rubbers is that the materials are strongly resistant to permeation by oxygen or to water vapor.
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