Thursday 22 March 2012

Why Empty Hard Gelatin Capsules are stored in Temperature & Humidity controlled area

Empty Hard Gelatin Capsules

Why Empty Hard Gelatin Capsules are stored in Temperature & Humidity controlled area?

Capsules are solid dosage forms in which medicinal agents are enclosed in a small shell. Depending on the composition capsules may be hard or soft. Hard gelatin capsules are made from gelatin (Gelatin is a translucent, colorless, brittle (when dry), flavorless solid substance, derived from the collagen- an animal protein).Empty Hard Gelatin Capsules contain 12 - 16% moisture. But the moisture content can vary up on the storage conditions.

Recommended Storage conditions for Hard Gelatin Capsules
Store capsules away from direct sunlight (e.g. windows and skylights)
Store capsules away from hot water/air radiators, hot water pipes and steam pipes.
Store capsules on pallets off the ground.
Store capsules away from potential sources of water condensation e.g. under water pipes.
Do not store empty capsules in freezers.
Hard gelatin capsules shall be stored between 15-25oC (68-75oF) and 45-55% relative humidity to maintain the 12-16% moisture content of capsules.

It is important that this moisture content is maintained and exposure to high temperatures or cycling between high/low temperatures is avoided. When humidity is low capsules become brittle, if stored at high humidity, the capsules become flaccid and the excess moisture content can interact with encapsulated product and can cause stability problems.

If capsules stored at high temperature following defects can occur
Stucking of capsules together in lumps and do not come apart.
Brittle or shatter capsules.
Capsules with distorted shape.
Stucking of capsule cap to body and resists separation. 

What is the difference between Hard Gelatin and Soft Gelatin Capsules?


Both the hard and softgel capsules are made of gelatin.Thus the difference between these two types of capsules lies in the design and manufacturing technology which are detailed below.
Hard Gelatin Capsule
Soft Gelatin Capsule
Made of hard gelatin
Made of soft gelatin
Produced in two halves consisting of a body and cap
Produced as a single piece of gelatin, rather than two halves attached
Mainly used for filling dry and powdered content
Mainly used for oil-based formulations
They’re manufactured using different machines, for shell production and encapsulation.
A different process is employed in manufacturing
Manufacturing and filling is done using the same machine, as part of a single process
Hard gel capsules usually are cylindrical
Can be made in a variety of shapes such as the oval, round, tube-like, fish-like, etc.
These are made of only hard gelatin, colorings, plasticizer and titanium dioxide
Lots of ingredients are used, i.e. soft gelatin, plasticizer, sugars, preservatives, colorings, opacifier, etc.
The ratio of gelatin and plasticizer is 1:0.4
The ratio of gelatin to plasticizer is 1:0.8
Available in a range of sizes
Size variety is limited

Size range of Hard Gelatin Capsules?

The capsule size ranges from 0.16 mils to 28 mils capacity (000,00,0,1,2,3,4,5)

Ingredients of Hard Gelatin Shell Capsules?
Gelatin, Dye, Plasticizer, Sugar, Edible colours, Opacifier, Glycerin, Preservatives

Hard Gelatin Capsules Disintegration Time?
Depending on the size of the capsules disintegration ranges from 3-13 minutes.

Major Steps in Hard Gelatin Capsule Shell Manufacturing
1.Gelatin Preparation 2.Dipping 3.Drying 4.Stripping and Trimming 5.Printing 6.Packing

Common Defects in Hard Gelatin Capsules

Shape
Dent,Bent,Double Cap,Mashed,Short and long caps & Bodies
Colour
Different colour, Discolour
Appearance
Dirt, Hole, Crack, Split, Telescoped, Foreign particle, edge, scrape
Printed Mark
No mark, Improper mark

Key words
Temperature and Humidity requirements for Hard Gelatin Capsules, Difference between Hard and Soft gel capsules, Size range of hard gelatin capsules, Disintegration time of hard gelatin capsules, Major steps in Hard Gelatin Capsules, Major ingredients of hard gelatin capsules, Hard Gelatin capsules major defects




27 comments:

  1. nice blog! & great information provided
    we provide capsule filling machinery, for more info please visit our site:

    www.capsulefillingmachine.in

    ReplyDelete
  2. I had no idea that this was why they always are so careful about how gelatin capsules are stored. Thanks so much for sharing this. I think I'm pretty much an expert now.

    ReplyDelete
  3. I didnt know this so thanks for posting this. I hadnt really heard about gelatin capsules untill a friend told me about the. So thanks again for posting this information.

    ReplyDelete
  4. Thank you for sharing I found this post to be very informative and helpful. I just purchased temperature controlled storage in MA and can’t wait to start using it!

    ReplyDelete
  5. Thanks for great information you write it very clean. I am very lucky to get this tips from you


    temperature controlled warehousing Canada

    ReplyDelete
  6. This comment has been removed by the author.

    ReplyDelete
  7. Dear thanks for the enriched information, kindly can you inform me by the reference of the storage conditions of EHGC if it is present in WHO etc

    ReplyDelete
  8. Thank you for this blog. That's all i can say..useful information shared...

    gelatin capsules

    ReplyDelete
  9. First of all i would like to thank you for the great and informative entry. I has to admit that I have never heard about this information I have noticed many new facts for me. Thanks a lot for sharing this useful and attractive information and I will be waiting for other interesting posts from you in the nearest future. Keep it up. gelatin capsules canada

    ReplyDelete
  10. Excellent and helpful post… I am so glad to left comment on this. This has been a so interesting read, would love to read more here….

    ReplyDelete
  11. Firstly I would like to thanks for shared useful information I really appreciate with your website I have heard about of the Gelatin Capsules basically there are two types of Gelatin Capsules one is the soft and 2nd hard Capsules.

    ReplyDelete
  12. Great article! That is a very neatly written article. Gelatin is one of those items which are intentionally or unintentionally are included in our daily routines. This is considered the daily supplement for our body which helps us to avail some those benefits which are not told to us before. Thanks for great share.

    ReplyDelete
  13. very interesting post.this is my first time here.i found so many interesting stuff in your blog especially its discussion..thanks for the post!Gelatin empty capsules

    ReplyDelete
  14. If this post interests you, then head straight to this blogger from California who has been in the business for 20 years now. He makes and sells empty caps of all sizes and varieties.

    You can read his blogs and watch Youtube videos to get a complete understanding of Empty Capsules, ways to fill them, determine the difference between a vegan and a gelatin cap and their consumption.

    https://emptycaps.com/blog

    ReplyDelete
  15. Thanks so much for your information! I am doing stability test for hard gelatin capsule but the storage conditions are not the same with your recommendation. For long term stability: temperature: 30C ± 2; humidity: 75%± 5%. For accelerated: temperature: 40C ± 2; humidity: 75%± 5%. These extremely affect appearance of capsule. Would you share me reference for stability test for empty and filled hard gelatin capsule? Many thanks!

    ReplyDelete
  16. A writer should always try to keep its writing very simple and clear. Always use facts which are easily acceptable by general people because they are very close to their assumptions and they welcome such kind of facts.mega we care ราคา

    ReplyDelete
  17. Uh. 15-25C is 59 - 77F, not 68-75F. Math skillz.

    ReplyDelete
  18. Dear sir,

    Good day, what will happen when we keep the gelatin capsules filled with API in 40 Deg celsius and 75 % humidity, does it affects the drug release on dissolution testing. we facing problem of releasing lower percent of API while doing dissolution
    Please suggest any suggestions regarding this

    ReplyDelete
  19. ACG recmmends storage temp of 15 to 30C & RH OF 40 -65% for HCG capsules

    ReplyDelete
  20. Samriddhi Group Best has a comprehensive range of herbal tablets, supplements & capsules free from contaminants and formulated to our high standards.


    Herbal Capsules
    Astha Win Capsules
    Energy Booster Capsules
    Flaxseed Oil Capsules
    Moringa Gold Capsule
    Punarnava Capsules
    Spirulina Capsules
    WinLeuco Lady Care

    ReplyDelete
  21. Excellent read, Positive site, where did u come up with the information on this posting?I have read a few of the articles on your website now, and I really like your style. Thanks a million and please keep up the effective work. medicines

    ReplyDelete
  22. Good Post and informative one. Thank you for sharing this good article.
    Buy Kratom Online Near Me

    ReplyDelete
  23. Hi There,
    Thank you for sharing the knowledgeable blog with us I hope that you will post many more blog with us:-
    Hydrocodone 10/325mg Bitartrate Prolonged-Launch Capsules might impair the psychological and Actual physical talents needed to perform potentially harmful things.
    Email:info@psychedeliconlinemall.com
    Click here for more information:- more info

    ReplyDelete
  24. Hi There,
    Thank you for sharing the knowledgeable blog with us I hope that you will post many more blog with us:-
    Buy Morphine 30mg Buy Morphine 30mg online. Since Morphine abuse can lead to addiction for many years this preparation has been available as a prescription-only drug. However, nowadays licensed web pharmacies are allowed to sell cheap it in a pill form.
    Email:info@psychedeliconlinemall.com
    Click here for more information:- more info

    ReplyDelete
  25. Usha Polycrafts is one of the best Capsules Container Manufacturers & suppliers in India. We are certified exporter of high quality capsule container at the best price. If you are looking Capsules Container services provider company so usha polycrafts is best option choose for this product. Contact us today for more details.

    ReplyDelete