Foils:
Foils are basically acts as primary barrier. Different types of foils are there acts as both base foil and lidding foil. Main role of foil is to protect the drug from Moisture, Light, and Contamination with external environment etc.
Examples for different types of foils based on composition.
1) PVC foil
2) PVC-PVDC foil
3) PVC-PE-PVDC foil
4) Cold formable foil
5) Aluminum foil
6) Paper backed Aluminum foil
7) ALU-ALU foil
8) Cold formable with Desiccant foil
The nature of the foil depends mainly on the Drug characteristics and its compatibility. Other factors include chemical composition of the Drug, Environment to be exposed, Market requirement and Price etc.
Properties of PVC film and Feature:
PVC films are the most popular plastic wraps that are made from Polyvinylidene Chloride (PVC). PVC films have excellent stretching properties that make them the most popular packaging films.
This PVC coating increases the barrier properties of the film and thus reduces the permeability of the film to oxygen and flavors. Therefore, PVC packaging extends shelf life of the Product inside the package.
PVC films provide controlled oxygen and water vapour transmission. They operate satisfactorily on high-speed packing machines. These plastic films offer exceptionally good stretch and are easily heat-sealed.
PVC films are temperature sensitive, developing a tendency to shatter and split at cold temperatures and shrink back or block when exposed to high temperatures. The color may also change to yellow when exposed to heat. They are ideal for blister packing of tablets, capsules, needles, syringes, vials, ampoules, ointment tubes, suppository packs, etc.
Cold-Form Foil:
Bottom foil for blistered products requiring the highest barrier properties.
Cold-form cavity, insert product, cover cavity with suitable lidding foil.
Benefits:
- Highly effective barrier to moisture and oxygen, even after cold forming.
- Total barrier to light.
- High mechanical properties: Tension at break: 150 N/15mm res. 57 lb./inch
Elongation at break: > 60% - Specifically adapted performance of each layer makes
the foil extremely cold-formable. - High dimensional stability after cold forming.
- Various three-dimensional draw ratios possible, including applications with extreme deep draw
requirements.
Closures and Containers:
Most commonly and widely preferable containers are HDPE Containers and Closures are of mainly CT & CRC plastic type (CT Closure Type, CRC Child Resistant Plastic Cap)
a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
Cartons:
Cartons are the secondary Materials which were having the details of the product/Material along with other info like Strength, Market, and Batch No: etc. these are generally Paper based Tuck in flap which helps to keep the blister Packs. Cartons are of different types – Printed, Plain, varnished etc. they gives physical protection as well information to the patient.
Self Adhesive Labels & Patient Information Leaflets:
Self-Adhesive labels give the additional Information like Material name, Type, Strength, Manufacture Batch No: Lot No: etc. mainly useful for Bottle packing.
Along with the Material description PIL provides the info like the way the drug reacts/functions, Symptoms/Side Effects (If any) with usage of that particular drug.
Appropriate Primary Pack
Desiccants have been utilized to control the exposure of products to the Ingress of moisture.
Desiccants vary in their capacity and the rate that they adsorb/absorb Ingresses moisture.
Silica gel is very efficient at absorbing moisture at high relative humidity, but comparatively poor at lower Relative Humidity.
Molecular sieve desiccants – the opposite scenario prevails. As a consequence, more molecular sieve is required at higher relative Humidity, and the greater the handling precautions that are required during
packaging operations.
Based on the calculated WVTR of known container components and the rate of moisture adsorbed by desiccants, the amount of desiccant that would be required to maintain a specified relative humidity over the product’s shelf-life can be determined and used.