newer trends in parentaral packaging

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

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› Introduction

› Various Packaging materials– Glass

– Rubber

– Plastic

› Various Container systems– Ampoules

– Vials

– Cartridges

– Bottles and Bags

– Blow/fill/seal Process

CONTENTS :

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• 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.

Introduction:

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› 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

Glass:

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› 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

Rubber:

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› 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

LAMINATED AREA

SEALED AREA

sealed area

L Laminated area

Advancement with the Flurotec® coating

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› 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

Plastic:

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› Glass sealed ampoules were the most popularprimary packaging system for small volumeinjectable products.

› Glass ampoules are Type I tubing glass in sizesranging from 1–50 ML

› Major Disadvantage with the ampoules is theproblem of glass particles entering thesolution when the ampoule is broken toremove the drug product.

Ampoules :

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› 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:

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› 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.

Vials:

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› Syringes are very popular delivery systemsthey are used either as empty sterilecontainer systems where solutions arewithdrawn from vials into the empty syringeprior to injection.

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› 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

Cartridges:

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› 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:

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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.

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› 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.

Conclusion

› Sacha G A, Clemmer W, Abram K. Practicalfundamentals of glass, rubber, and plastic sterilepackaging systems. Pharmaceutical Developmentand Technology . 2010 February; 15(1): 6–34

› 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): 98–110 Availablefrom www.ncbi.nlm.nih.gov

› Blow fill seal process. Catalant; 2012 August 29.Available fromwww.youtube.com/watch?v=bw6vMQ7jDHE

References:

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THANK YOU!

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