About albumin tannate
Albumin tannate manufacturers include Medice in Germany (Tannalbin tablets) and several Japanese producers of Japanese Pharmacopoeia albumin tannate powder. Albumin tannate (tannin albuminate) is a heat-treated compound of protein and tannic acid that slowly releases tannin in the gut. It is used as an astringent antidiarrhoeal. Pharmaceutical companies can source albumin tannate tablets, powder and API through out-licensing, supply or technology transfer.
Albumin tannate key facts
|
Property |
Albumin tannate |
|---|---|
|
Common names |
Albumin tannate; tannin albuminate; tannic acid albumin |
|
Chemical description |
Protein (albumin) combined with tannic acid and hardened by heat |
|
CAS number |
9006-52-4 |
|
ATC code |
A07XA01 |
|
Drug class |
Antidiarrhoeal; intestinal astringent |
|
Brand names |
Tannalbin (Germany); Japanese Pharmacopoeia albumin tannate (several makers) |
|
Dosage forms and strengths |
Tablets 500 mg (Germany); oral powder (Japan) |
|
Protein source |
Egg albumin in German Tannalbin; Japanese products are contraindicated in milk allergy |
|
Indications |
Diarrhoea (non-specific) |
|
Germany |
Tannalbin 500 mg tablets, Medice, authorised 15 September 2003; non-prescription |
|
Japan |
Japanese Pharmacopoeia monograph; products marketed since 1953 |
|
Japanese API master files |
Nikko Pharmaceutical; Yashiro Pharmaceutical |
Albumin tannate manufacturers and licensing history
Albumin tannate is an old antidiarrhoeal with no single originator. It is made by heating tannic acid with protein at 110–120 °C for several hours, which gives a compound that releases tannin slowly in the intestine.
In Germany, Medice markets Tannalbin 500 mg tablets, made with egg albumin. The current authorisation dates from 15 September 2003, and the product is sold freely without prescription.
In Japan, albumin tannate is listed in the Japanese Pharmacopoeia and sold as powder by several companies, with products on the market since 1953. Japanese products are contraindicated in people with milk allergy. Nikko Pharmaceutical and Yashiro Pharmaceutical hold Japanese master files for the API.
Buyers should confirm the protein source (egg or milk), GMP status and pharmacopoeial standard before choosing a supplier.
Albumin tannate dosage forms and dossier types
Albumin tannate is supplied as 500 mg tablets in Germany and as oral powder in Japan.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Albumin tannate tablets |
500 mg |
EU national dossier |
Reference Tannalbin; non-prescription |
|
Albumin tannate oral powder |
Bulk powder for dispensing |
Japanese dossier |
Japanese Pharmacopoeia standard |
|
Albumin tannate API |
Bulk |
Japanese master file |
Protein source must be declared |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
Germany, EU |
National CTD |
Reference Tannalbin; egg allergy labelling |
|
Japan |
Japanese CTD |
Japanese Pharmacopoeia; milk allergy contraindication |
|
Other markets |
National |
Check local antidiarrhoeal rules |
Albumin tannate regulatory and patent status
Albumin tannate is off-patent and long established. It is classified under ATC code A07XA01. In Germany, Tannalbin is a non-prescription medicine. In Japan, albumin tannate is a pharmacopoeial product, sold by several companies.
Albumin tannate mechanism of action and therapeutic use
Albumin tannate passes through the stomach and slowly releases tannin in the intestine. Tannin binds proteins on the gut lining, which has an astringent effect and reduces secretion. It does not produce measurable tannin levels in the blood. Albumin tannate is used for non-specific diarrhoea. It should be taken several hours apart from iron preparations, which tannin can inactivate.
Albumin tannate licensing and sourcing
Albumin tannate suppliers and licensing partners typically offer finished-product supply, dossier out-licensing or API supply. Buyers usually compare GMP status, protein source, pharmacopoeial standard and territory availability. Current offers and supplier contacts are listed among the albumin tannate manufacturers on Pipelinepharma.
Frequently asked questions about albumin tannate
Who are the main albumin tannate manufacturers? Medice makes Tannalbin tablets in Germany. In Japan, several companies sell Japanese Pharmacopoeia albumin tannate powder, and Nikko Pharmaceutical and Yashiro Pharmaceutical hold API master files.
Is albumin tannate a prescription medicine? In Germany, Tannalbin tablets are sold without prescription. Status varies by country.
Is albumin tannate safe for people with allergies? It depends on the product. German Tannalbin is made with egg albumin, and Japanese products are contraindicated in milk allergy. Labels should state the protein source.
What forms and strengths of albumin tannate are available? Albumin tannate is available as 500 mg tablets in Germany and as oral powder in Japan.
Does albumin tannate interact with other medicines? Yes. Albumin tannate can make iron preparations less effective, so the two should be taken several hours apart.
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