Bloom Strength Test: Quality Control for Capsules

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Questions and Answers

What is the advantage of using plastic containers over cardboard boxes for capsules?

They are more convenient to handle and transport

What is placed over and under the capsules in the vials to prevent them from rattling?

Cotton tuft

What is placed in vials containing very hygroscopic capsules to prevent the absorption of excessive moisture by the capsules?

Packet-containing desiccant like silica gel

What provides sanitary handling of medicines, ease in counting, and identification for capsules?

Strip packaging Signup and view all the answers

What are the physical properties of gelatin capsule shells that should be assayed?

Bloom strength, viscosity, and loss Signup and view all the answers

What is used to measure the cohesive strength of the cross-linking that occurs between gelatin molecules?

Bloom strength Signup and view all the answers

How is Bloom strength determined?

By measuring the weight in grams required to move a plastic plunger into gelatin gel at a specific temperature for a certain duration Signup and view all the answers

What does the higher bloom value indicate about the gelatin used for capsule shells?

Higher melting and gelling point of gel Signup and view all the answers

What does the higher Bloom strength of gelatin used result in for the capsule shell?

More physically stable resulting capsule shell Signup and view all the answers

Which category of gelatin has a bloom number range from 225-325?

Higher bloom Signup and view all the answers

What is the primary purpose of liquid encapsulation technology?

To address issues associated with softgel capsules Signup and view all the answers

What is the primary difference between hard gelatin capsules and soft gelatin capsules?

Hard gelatin capsules have a thicker gelatin shell than soft gelatin capsules Signup and view all the answers

What is the source of Type A gelatin used in capsules?

Beef skin Signup and view all the answers

What is the purpose of disintegration tests for gelatin capsules?

To ensure that the drug substance is fully available for dissolution and absorption Signup and view all the answers

What is the primary concern addressed by physical stability tests for soft gelatin capsules?

The pick-up or loss of water by the capsule shell Signup and view all the answers

What is the purpose of weight variation tests for gelatin capsules?

To determine the net content of individual capsules Signup and view all the answers

What is the chemical nature of gelatin used in capsules?

Protein Signup and view all the answers

'Type A' gelatin has an isoelectric point in the region of pH:

$6-7$ Signup and view all the answers

'Green bones' are used for the preparation of which type of gelatin?

'Type A' gelatin Signup and view all the answers

'Type A' gelatin is obtained by:

$acid$ hydrolysis Signup and view all the answers

What is the advantage of using HPMC capsules for moisture-sensitive products?

Low moisture content (3–8%) and low static charge Signup and view all the answers

Which type of capsules is suitable for enteric coating due to its pH independent dissolution?

Starch capsules Signup and view all the answers

Which type of capsules is used to avoid the risk of contamination with organisms causing BSE or TSE?

HPMC capsules Signup and view all the answers

Which type of capsules is suitable for filling insoluble drugs dissolved in polyethylene glycol (PEG) 400?

Polyvinyl acetate (PVA) capsules Signup and view all the answers

Which type of capsules is suitable for use in a wide range of OSD pharmaceuticals as well as nutraceuticals, dietary supplements, and herbal products?

HPMC capsules Signup and view all the answers

What is the moisture content range of starch capsules?

12–14% w/w Signup and view all the answers

What material are PVA capsules made from?

PVA Signup and view all the answers

What type of capsules have low oxygen permeability, resulting in a high barrier to oxygen?

(PVA) capsules Signup and view all the answers

Which type of capsules is made from natural, safe, non-allergenic, clean, and economical ingredient?

(HPMC) capsules Signup and view all the answers

Study Notes

Two-piece hard capsules made of gelatin or HPMC can be used for filling various non-aqueous liquids, pastes, suspensions, and hot melts, as well as for moisture-sensitive drugs.
Liquid encapsulation technology helps overcome problems associated with softgel capsules, such as high cost, waste, cross-contamination, and low bioavailability.
Gelatin used for liquid-filled capsules has a higher bloom strength (approximately 220-280 for hard capsules and 150-200 for softgels).
Soft gelatin capsules (SGC) have soft, globular, gelatin shells thicker than hard gelatin capsules, which are plasticized by the addition of glycerin, sorbitol, or similar polyols.
Capsules may contain preservatives to prevent fungal growth.
Gelatin is a natural substance derived primarily from animal skin and bones, and is chemically a protein.
The smallest capsule size is denoted by number '0'.
Type A gelatin is normally derived from beef skin, and is the hydrolyzed product of collagen.
Type A gelatin has an isoelectric point in the region of pH 6-7.
Green bones are used for the preparation of Type A gelatin.
Type A gelatin is obtained by acid hydrolysis.
In-process and finished product quality control tests are conducted for both soft and hard gelatin capsules.
Weight variation tests are used to determine the net content of individual capsules and the weight range limits for both hard and soft gelatin capsules.
Disintegration tests are conducted to ensure that the drug substance is fully available for dissolution and absorption from the gastrointestinal tract.
Dissolution tests are used to evaluate the amount of active ingredient released from the capsules under specified conditions.
Physical stability tests, including capsule fragility or rupture tests, are conducted to ensure the integrity of the gelatin shell and to test the effect of storage conditions on the capsules.
The physical stability of soft gelatin capsules is primarily associated with the pick-up or loss of water by the capsule shell.
Capsule stability or shelf life tests are conducted to evaluate the effect of storage conditions on the capsules and to ensure the lack of growth of bacteria and molds.
Capsules should be packed in well-closed containers and stored in a cool place to maintain their physical stability.

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Capsules Quality Control Tests