Title: Development and pharmaceutical properties of a new oral dosage form of theophylline using sodium caseinate for the possible use in elderly patients
Abstract: Abstract As a new oral dosage form which elderly patients could handle and swallow more easily, a solid mass containing theophylline was formed by treatment of a powder mixture of sodium caseinate, microcrystalline cellulose and theophylline with moist heat in the form of saturated steam under pressure. The physical and chemical stability of theophylline in solid mass form was confirmed on the basis of data obtained by infrared spectroscopy, X-ray powder diffractometry and high-performance liquid chromatography. The solid mass containing theophylline showed lower water absorption and reduced swelling tendency compared to the theophylline-free solid mass, whereas the slope of the gel destruction curve of swollen mass containing theophylline was similar to that of the theophylline-free solid mass. Therefore, it appeared that elderly patients could swallow this dosage form easily. The rate of release of theophylline from the swollen mass decreased in the order of distilled water, JP XII disintegration test fluid no. 2 (pH 6.8), and JP XII disintegration test fluid no. 1 (pH 1.2). The profiles of theophylline release from the swollen mass demonstrated non-Fickian diffusional behavior. In JP XII disintegration test fluid no. 1, theophylline was released slowly from the whole swollen mass, but rapidly from the destroyed swollen mass. The presence of digestive enzyme (pepsin) increased the release rate of theophylline from the swollen mass gradually. Thus, the structure of the polymer network in the swollen mass was considered to influence the release profile of theophylline. Although the biopharmaceutical parameters of this new oral dosage form should be further examined, the dosage form using sodium caseinate seems to be useful for medication in elderly patients.
Publication Year: 1995
Publication Date: 1995-04-01
Language: en
Type: article
Indexed In: ['crossref']
Access and Citation
Cited By Count: 7
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot