Official Pharmacopoeia Research Articles

The First Official Estonian Pharmacopoeia

The First Official Estonian Pharmacopoeia

Dissolution of Omeprazole from Delayed-Release Solid Oral Dosage Forms

The evaluation of the biopharmaceutical quality of omeprazole enteric-coated products (granules in capsules) with respect to its dissolution characteristics is not specifically regulated in any of the most common official pharmacopoeia. USP 23 includes a general monograph for enteric-coated products. This paper reports the evaluation of the medium pH effect on the dissolution rates of omeprazole from four omeprazole-containing products of different manufacturers. It is concluded that the USP 23 recommended dissolution procedure for enteric-coated products is not suitable due to the degradation of omeprazole under such conditions. Furthermore, the medium with pH 8.0 showed different dissolution rates not observed at pH 7.4, allowing discrimination between products of different manufacturers.

Degradation of hydroxypropylcellulose by Rhizomucor: effects on release from theophylline–hydroxypropylcellulose tablets

The stability of several varieties of hydroxypropylcellulose was monitored during 3 years of storage (1) under the conditions recommended by manufacturers and official pharmacopoeias (simple storage in closed containers) and (2) at zero relative humidity. After 1 year, severe degradation of the varieties with lower initial pH and particle size stored at ambient relative humidity was shown by changes in their molecular weight and in the pH and apparent viscosity of 2% aqueous dispersions. Microbiological analyses showed the observed degradation to be attributable to the action of fungi of the genus Rhizomucor. The changes in apparent viscosity significantly affected the release of theophylline from direct compression tablets formulated with the degraded excipients.

Silent revolution in the library: Electronic media replace printed products

The official pharmacopoeias in the central library of Boehringer Mannheim, a research‐based German pharmaceutical company, are taken as an example to demonstrate the switch from printed versions to electronic media. Preparatory work, practical procedure and results of this action are shown. Motives for the switch, economic questions and the consequences for all persons involved are described.

Efficacy of a pancreatic enzyme formulation in the treatment of steatorrhea in patients with chronic pancreatitis

The effect of an acid-protected pancreatic enzyme preparation was evaluated in 10 patients with chronic pancreatitis and steatorrhea. (Twelve patients were enrolled but two withdrew because of poor compliance.) Fecal fat excretion and stool weight were measured, a p-aminobenzoic acid (PABA) test was performed, and gastrointestinal symptoms were assessed before and after 4 weeks of treatment with a standardized dose of pancreatic enzymes (two capsules three times daily, each capsule containing 13,000 FU [Italian Official Pharmacopeia] units of lipase). After treatment, we observed a statistically significant reduction in fecal fat excretion and stool weight as well as improved PABA test results and symptoms. This study confirmed the efficacy of this pancreatic enzyme preparation in the treatment of patients with pancreatogenic steatorrhea.

Colorimetric Determination of Sympathomimetic Amines Methyldopa and Noradrenaline

The chromogenic reagent p-dimethylaminocinnamaldehyde (PDAC) is introduced for the determination of the sympathomimetic amines methyldopa and noradrenaline. The method is based on measurement of the orange color developed when the alkaline solution of methyldopa and noradrenaline is allowed to react with PDAC at pH 5.0. The color developed obeys Beer's law in the concentration range 0.1-1.5 mL of 2 X 10(-3)M solution of noradrenaline and methyldopa. The results are compared with those obtained with another chromogenic reagent, p-dimethylaminobenzaldehyde (PDAB). Determinations on dosage forms of the drugs, using PDAC and PDAB reagents, agreed well with results of determinations by official pharmacopoeial methods.

Determination of purity and identification of animal sources of insulin in various insulin preparations.

Prolonged administration of insulin leads to the formation of insulin-binding antibodies due to contaminant peptides and the animal source of the insulin. It follows that quantitation and identification of these factors are of significant importance in pharmaceutical insulin preparations. The assay and test procedures stipulated in the current pharmacopoeia of various countries, nevertheless, cannot determine either of these effects. In the present study, the content of impurities in insulin preparations was measured by polyacrylamide gel disc electrophoresis and the animal source of insulin identified by amino acid analysis. Assays of 17 commercial insulin preparations by these techniques revealed diversity in purity and animal sources of insulin. The present results suggest potential usefulness of these assay methods and advisability of their adoption not only by the manufacturers but also by the official pharmacopoeia as well.

Determination of Purity and Identification of Animal Sources of Insulin in Various Insulin Preparations

Prolonged administration of insulin leads to the formation of insulin-binding antibodies due to contaminant peptides and the animal source of the insulin. It follows that quantitation and identification of these factors are of significant importance in pharmaceutical insulin preparations. The assay and test procedures stipulated in the current pharmacopoeia of various countries, nevertheless, cannot determine either of these effects. In the present study, the content of impurities in insulin preparations was measured by polyacrylamide gel disc electrophoresis and the animal source of insulin identified by amino acid analysis. Assays of 17 commercial insulin preparations by these techniques revealed diversity in purity and animal sources of insulin. The present results suggest potential usefulness of these assay methods and advisability of their adoption not only by the manufacturers but also by the official pharmacopoeia as well.

ABOUT THE COVER: THE FIRST OFFICIAL PHARMACOPOEIA

Journal of School HealthVolume 47, Issue 5 p. 301-303 ABOUT THE COVER: THE FIRST OFFICIAL PHARMACOPOEIA First published: May 1977 https://doi.org/10.1111/j.1746-1561.1977.tb01068.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume47, Issue5May 1977Pages 301-303 RelatedInformation

Unofficial Pharmacopeias

THE last British Pharmacopeia was published in 1914;. a new one is now in preparation and is due to appear in 1931. In the interval, the United States has produced two official pharmacopeias, the ninth in 1916 and the tenth in 1926. The long intervals between successive editions, the wise conservatism of pharmacopeial commissions, and the limitations imposed upon pharmacopeias by their legal status, make it inevitable that there must always be a huge materia medica which does not find official recognition, and this is the happy hunting ground of the compiler of dispensatories, formularies, pharmacopeial companions, and in general of the mass of literature which may be grouped together as ‘unofficial pharmacopeias’. Such literature is indispensable to the busy pharmacist and medical man, as is evident from the fact that the two books now under review are in their nineteenth and tenth editions respectively. They both supplement the official pharmacopeia and they are complementary to each other. (1) The Extra Pharmacopœia of Martindale and Westcott. Revised by Dr. W. Harrison Martindale. Nineteenth edition. In 2 volumes. Vol. 2. Pp. xxxviii + 759. (London: H. K. Lewis and Co., Ltd., 1929.) 22s. 6d. net. (2) Pharmaceutical Formulas. P.F. Vol. 1 being The Chemist and Druggist Book of selected Formulas from the British, United States, and other Pharmacopœias, together with Non-Official Formulas from various Sources. Tenth edition, entirely revised and rewritten. By S. W. Woolley and G. P. Forrester. Pp. xvi + 1146. (London: The Chemist and Druggist, 1929.) 15s.