Cross Linking of Gelatin Capsule Shells Agilent

Cross Linking Of Gelatin Capsule Shells Agilent-Free PDF

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Gelatin and Cross Linking,USP Procedure pre 40 6,40 6 Revisions to USP 711 and. Prevention of Cross Linking,What is Gelatin,Hydrolyzed form of collagen. Collagen is obtained from various,animal by products. Used as a gelling agents in a,variety of applications. Photography,Pharmaceuticals,What is Cross Linking, Cross linking is the formation of strong chemical linkages.
beyond simple hydrogen and ionic bonding between gelatin. Reaction is generally irreversible,Renders gelatin insoluble. Reaction catalyzed by a number of chemical and,environmental factors. From USP Stimuli to the Revision Process Use of Enzymes in the Dissolution Testing of Gelatin Capsules. and Gelatin Coated Tablets Revisions USP PF 40 6,Gelatin Structure. Protein with some potentially reactive side chains. Often will form helices etc, Can form covalent and hydrogen bonds between itself and. another chain, Cross linking can occur in collagen as condensation products.
between aldehydes and amines or between two aldehydes. Gelatin more prone to cross linking than collagen,What can cause Cross Linking in Gelatin. Aldehydes and Ketones, APIs with carbonyl groups or potential aldehyde formation. Oxidizing agents,Metal Ions,High and Low Humidity, Looking at it funny just kidding but it s very reactive. Cross Linking Impact,Capsule shell opening is delayed or. stopped by pellicle formation on the,internal or external gelatin surface.
Visually confirmed with seeing thin,membranes or gelatinous masses. Cross linking amount can be,determined by other methods. NMR UV Fluorescence,Spectroscopy MRI Near IR,Spectroscopy. Cross Linking Impact,Lower and or incomplete dissolution in. In severe situations can lead to,problems in vivo as well.
Cross linking most commonly seen in,stability testing. Pictures used courtesy of Vivian Gray 2014,Current USP Approach. to Cross linking, For hard or soft gelatin capsules and gelatin coated tablets that. do not conform to the Dissolution specification repeat the test. as follows, Media pH 6 8 repeat test with addition of purified pepsin. 750 000 units L, Media pH 6 8 repeat test with addition of pancreatin.
1750 USP units of protease activity L, Digestive enzyme in stomach which converts proteins to. For cross linking this is used to clean gelatin proteins in. places other than cross linking site and allow rupture. Typically obtained from glandular layer of hog stomach. Peak activity at pH 2 good activity to pH 4 5,Pancreatin. Mixture of digestive enzymes created by exocrine cells of. Typically porcine bovine origin,Has good protease activity. Peak Activity at pH 6 8 good between 6 8,Success with USP 711. Pepsin activity generally felt sufficient to deal with mild to. moderate cross linking,Pancreatin able to handle mild cross linking.
Limitations with USP 711,No good enzymes for pH 4 6 8. Surfactant Enzyme incompatibility,SLS and other surfactants can denature enzymes. Other enzymes can enhance activity,Pancreatin levels too low. Cross linking is the formation of strong chemical linkages beyond simple hydrogen and ionic bonding between gelatin chains Reaction is generally irreversible Renders gelatin insoluble Reaction catalyzed by a number of chemical and environmental factors From USP Stimuli to the Revision Process Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin Coated

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