Method of preparing an oral preparation provided on the outer si

Details Method of preparing an oral preparation provided on the outer si Method of preparing an oral preparation provided on the outer si

1997-12-15

1999-03-16

Dudash, Diana

Coating processes

Medical or dental purpose product; parts; subcombinations;...

Particulate or unit-dosage-article base

427 219, 427 221, 427426, 424457, 424460, 424461, 424463, 424472, 424476, 424477, 424479, 424491, 424493, A61J 300, A61K 936, A61K 938, A61K 942

Patent

active

058827153

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The present invention relates to a method of preparing an oral preparation, especially in the form of hard gelatin capsules, tablets, powders or pellets, said preparation on the outer side being provided with an enteric coating resistant to the acid environment in the stomach and containing or comprising a calcium salt of a polysaccharide, where a moisture-resistant layer containing a protein is provided between the material to be coated and the coating applied and optionally also on the outer side of the coating. The method according to the invention is characterised in that the enteric coating is formed in a fluidized bed, where both a liquid containing calcium ions and a liquid containing the anion of a soluble salt of a polysaccharide are sprayed onto the material to be coated.


BRIEF DESCRIPTION OF THE INVENTION

The oral preparation prepared according to the invention is a solid substance, for instance in form of tablets, capsules, pellets, powders or granules to be used by the administration of drugs or supplementary nutrients for human beings or animals, a coating in form of an enteric film being applied onto said substance. To be more precise, a coating is applied onto the solid substance, said coating being of such a nature that upon administration to a human being or an animal said coated substance is substantially unaffected by chemical, enzymatic or other conditions prevailing in the stomach while said substance passes through this portion of the digestive system. Subsequently, the substance is, however, in the process of dissolution or is disintegrating in another manner in the intestinal canal with the result that the drug or supplementary nutrients contained in the solid substance are released. Such preparations are also known as for instance "gastro-resistant", "entero-soluble", "enterically coated", or simply "enteric" preparations.
Many situations apply where it is very important or at least advisable to provide an enteric film coating on preparations to be orally administered.
Such situations are for instance the following: substance, contained in the preparation remains intact until it reaches the absorption site in the intestinal canal without having been subjected to a previous disintegration in the stomach. Thus, several drugs of major medicinal importance, such as some antibiotics and some antiinflammatory and antineoplastic agents are easily and quickly decomposed under the chemical and enzymatic conditions or other conditions prevailing in the gastric juices of human beings and animals, whereby these drugs lose their therapeutical effect before they reach the absorption site. Therefore it is necessary to ensure that such drugs for oral administration are able to resist the passage through the stomach in such a manner that they can remain intact until they reach the intestinal canal and without losing the desired effect. Preparations are also known which contain live (such as freeze-dried) bacteria, such as Lactobacillus acidophilus, which cannot survive the low pH-values in the stomach. Such live bacteria are used for the prevention or treatment of stomach infections. adverse effects, such as ulcerogenic effects related to the taking in of drugs such as acetylsalicylic acid (which is widely used as an analgetic and also increasingly used for the prevention or therapeutical treatment of cardiovascular diseases), sodium chloride (which for instance is used instead of physiological salt), potassium chloride (which is orally administered in connection with treatment with diuretics or as a replacement of sodium chloride) or ammonium chloride (which for instance is used for the treatment of metabolic baseosis). instance an antiinflammatory agent or a digestive enzyme in a specific location in the intestinal system in order to provoke a specific, local effect. unpleasant taste or smell or which at release in the stomach can be nauseating or cause other undesired effects in order to ensure that said substance is not released until it has passed the stomach whether or no

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C.B. Abletshauser, et al., "Film Coating of Pellets with Insoluble Polymers Obtained in Situ Crosslinking in the . . . " Journal of Controlled Release, vol. 27, 1993, pp. 149-156 (no month).
A. Polk, et al., "Controlled Release of Albumin from Chitosan-Alginate Microcapsules" Journal of Pharmaceutical Sciences, vol. 83, No. 2, Feb. 1994, pp. 178-185.

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