Health & Medicine
Submitted byAbhishek Sunil Dhoot (160603003)
First Year MPharm (Pharmaceutics)
Under the guidance ofDr. Anup Naha
NEWER TRENDS IN PARENTARALS PACKAGING
Department of Pharmaceutics
EVALUATORY SEMINAR ON
Various Packaging materials Glass
Various Container systems Ampoules
Bottles and Bags
Sterile product packaging systems consist of glass,rubber, and plastic materials that are in intimatecontact with the formulation.
There are six basic primary packaging or containersystems:
1. Ampoules glass
2. Vials glass and plastic
3. Syringes glass and plastic
4. Cartridges glass
5. Bottles glass and plastic
6. Bags plastic
Rubber is used in Closures for vials and bottles,plunger and seal in syringes etc.
A Glass is primarily composed of the elementsilicon.
Classification of glass:
Type I, a borosilicate glass.
Type II, a soda-lime with a chemical surfacetreatment.
Type III, a soda-lime glass.
Type IV NP, a soda-lime glass not suitable forcontainers for Parenterals
In the injectable drug product business, rubber isused for many applications
Closures for vials and bottles
Seals and plungers for syringes and cartridges,
Gaskets in manufacturing equipment
Advances in rubber closure technologies haveintroduced closures with special polymer coatingor laminate
Advancement with the Flurotec coating is a stopper calledLyoTec.
The top surface of the LyoTec stopper is treated with Flurotec.This prevents the stopper from sticking to the top pressure platesof the freeze dryer shelves and either coming completely off of thevial or having the stopper plus the vial stick to the shelf above
The Flurotec is a barrier laminate protecting the drug productfrom the rubber formulation.
Flurotec treated surface
L Laminated area
Advancement with the Flurotec coating
Plastics are widely used for parenteral drugcontainers and administration devices.
Thermoplastics are polymers that soften uponheating and solidify upon cooling with theseprocesses being reversible.
Most parenteral packaging are thermoplastics
Glass sealed ampoules were the most popularprimary packaging system for small volumeinjectable products.
Glass ampoules are Type I tubing glass in sizesranging from 150 ML
Major Disadvantage with the ampoules is theproblem of glass particles entering thesolution when the ampoule is broken toremove the drug product.
SafeBreaK is a safety ampoule breaker and itavoids dangerous glass filing required duringbreaking the ampoule.
No gauze pads necessary to protect hands.
SafeBreaK prevents cross contamination
Safety ampoule breaker:
The most common packaging for liquid and freeze-dried injectables is the glass vial.
Plastic is also used
Plastic vials are made of cyclic olefin copolymer (COC).
The appearance of a plastic vial looks identical to a glass vial.
Syringes are very popular delivery systemsthey are used either as empty sterilecontainer systems where solutions arewithdrawn from vials into the empty syringeprior to injection.
In cartridges the drug product is filled into a glasstube.
Cartridges are inserted into delivery pens.
Cartridge/pen delivery systems are used primarilyfor multiple dose proteins such as insulin andgrowth hormone
Bottles and bags typically refer to containerslarger than 100 ML.
Large volume injectable solutions or emulsionsare contained in bottles or bags rather than vials
Bottles can be glass or plastic
Polyvinyl chloride (PVC) was the polymer materialof choice for many years for bags
Bottles and bags:
BLOW/FILL/SEAL Process: Aseptic blow-fill-seal (BFS) technology is
the process by which plastic containers areformed, filled with sterile filtered productand sealed in an uninterrupted sequenceof operations within the controlled sterileenvironment of a single machine.
Sterility is very important in parenteral formulation and Packaging system plays very crucial role in it . Its keeps the drug safe and sterile from contamination and protects from environmental conditions.
Sacha G A, Clemmer W, Abram K. Practicalfundamentals of glass, rubber, and plastic sterilepackaging systems. Pharmaceutical Developmentand Technology . 2010 February; 15(1): 634
Zadbuke N, Shahi S, Gulecha B, Padalkar A, andThube M. Recent trends and future ofpharmaceutical packaging technology. J PharmBioallied Sci. 2013 Apr-Jun; 5(2): 98110 Availablefrom www.ncbi.nlm.nih.gov
Blow fill seal process. Catalant; 2012 August 29.Available fromwww.youtube.com/watch?v=bw6vMQ7jDHE
file:///F:/Seminar Data/S1/Sources/Recent trends and future of pharmaceutical packaging technology.htmhttp://www.ncbi.nlm.nih.gov/http://www.youtube.com/watch?v=bw6vMQ7jDHE
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