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PubMed2001

[Quo vadis, Pharmacopoeia Hungarica?].

The authors give an overview on the present role of the 7th Edition of the Hungarian Pharmacopoeia in the assurance of the good quality of medicines in Hungary. The reasons for the more and more limited applicability of the pharmacopoeia conflicting with its legal validity are shown for the most important groups of medicines. The authors, members of the presidium of the Hungarian Pharmacopoeia Commission, outline the future face and the timing of the publication of the 8th edition of the Hungarian Pharmacopoeia, which is intended to consist of the translations of the general chapters and monographs of the 3rd and 4th Editions of European Pharmacopoeia as well as of the so called national volume with monographs not included in the EP but harmonized with its general chapters. The impact of the new pharmacopoeia on the different fields of pharmacy and the necessary measures to be taken to make the switch-over from Ph. Hg. VII to Ph. Hg. VIII as smooth as possible are also summarised in the paper.

Europe↗
PubMed1975

[Pharmacopoeia and veterinary medicine].

The A recalls briefly the evolution of the veterinary pharmacopoeias. They were at first national and became later international. The A. describes the situation of the veterinary drugs and of their inclusion in the national pharmacopoeias, as far as the European countries are concerned. Are we supposed to assign to them, because of their specificity, a special section in the pharmacopoeia or should we set up a special pharmacopoeia for them? In view of the effects they have on public health should we incorporate them into the pharmacopoeia in the same forms as the human drugs? The A. relates the arguments in favor of each of these points of view. Whichever the decision will be taken to solve this problem, the A. emphasizes the usefulness of the insertion of veterinary drugs in a pharmacopoeia, because of the improper use that some countries make of this type of drugs and because of the consequences this use can possibily have on public health.

Aged↗
PubMed2001

A case study of preservation of semi-solid preparations using the European Pharmacopoeia test: comparative efficacy of antimicrobial agents in zinc gelatin.

The present study was undertaken with the aim of finding an alternative preservative system to methyl parahydroxybenzoate in zinc gelatin, which was described in the monographs of the Swiss Pharmacopoeia (until Ph. Helv. 8) and in previous editions of the German Pharmacopoeia (until DAB 7). This antimicrobial agent has now been withdrawn in the DAB, because of its potential allergy risks. As for the USP and DAB-DDR zinc gelatin preparations, they have always been devoid of any preservative agent, probably relying on the mild antimicrobial activity of zinc. A literature survey did not reveal if such an aqueous preparation containing the water-insoluble zinc oxide shows efficacious antimicrobial activity by itself. Thus, a comparative evaluation of differently preserved zinc gelatin preparations was performed using a test for the efficacy of antimicrobial preservation that has been modified with regard to the European Pharmacopoeia (EP) test to take into account the solid state of the preparations and the bactericidal effect of the zinc. Three zinc gelatin preparations were checked, either: (i), without any agent; or (ii), with 0.1% methyl parahydroxybenzoate; or (iii), with 0.5% phenoxyethanol, a broad-spectrum antimicrobial agent almost devoid of allergy risks. The three preparations behave quite differently, in particular with respect to fungi. All three preparations passed the modified EP test as far as bacteria are concerned. Even zinc gelatin without preservative is very effective, not only because of the mild antimicrobial activity of zinc (the soluble fraction of zinc oxide in the liquid phase of zinc gelatin was determined to be 13 microg/ml), but most probably because of the low water activity of the preparation (measured as around 0.81), as shown by the absence of growth of a zinc-resistant strain of Pseudomonas aeruginosa. Zinc gelatin preserved with methyl parahydroxybenzoate has a weak, although satisfactory, activity against Staphylococcus aureus. Regarding fungi, gelatin without an antimicrobial agent and that preserved with methyl parahydroxybenzoate meet the requirements for efficacy against Candida albicans, but are only bacteriostatic against Aspergillus niger. As for zinc gelatin preserved with phenoxyethanol, it displays the best activity against C. albicans and, above all, appears to be the only formulation exhibiting fungicidal activity against A. niger. It is therefore recommended to preserve zinc gelatin with this antimicrobial agent, as recently adopted in Supplement 2000 of the Swiss Pharmacopoeia.

Anti-Bacterial Agents↗
PubMed1999

[ICH4 and pharmacopoeias: similarities and differences].

Since 1990, the pharmacopoeias have been regularly consulting each other on their programmes of work and have set up a Pharmacopoeial Discussion Group. This group meets regularly (twice a year) in Europe, Japan and the United States. About fifty monographs on excipients and general methods of analysis proposed by national associations of manufacturers of pharmaceutical products have been selected for convergence and harmonization among the three pharmacopoeias. The pharmacopoeias also participate in the work on the rapprochement of licensing dossiers within the framework of the cycle of international conferences known as ICH organised by the licensing authorities and manufacturers' associations of Europe, Japan and the United States. The pharmacopoeias have observer status in the QWP and Biotech WP and notably have participated in the elaboration of guidelines on analytical validation, impurities, residual solvents and specifications. If necessary, they integrate the general principles of these guidelines into their specifications.

Europe↗
PubMed1975

The role of the pharmacopoeia in the control of pharmaceutical preparations.

Pharmacopoeia commissions have a responsibility to protect the public in the sphere of medicines against error, ignorance or fraud. This responsibility is discharged by defining the standards with which the substance shall comply when offered for medicinal use and the methods by which compliance will be adjudged. The pharmacopoeia is one instrument among several which have been developed by society for ensuring safety in the use of medicines. Others are: -control by legislation over the training and practice of pharmacists; -limitation of the supply of certain medicines to doctors' prescriptions; -the limitation of sale to pharmacists (in most European countries) of all but a small proportion of medicines; -inspection for licensing of premises in which medicines are manufactured; -evaluation by expert committees of the formulations proposed by manufacturers and registration of such formulations for sale; -analysis of samples of medicines on the market. Many pharmacopoeias, including those having the widest territoral application, include monographs on pharmaceutical preparations. Others restrict their interest to the substances used as medicines. The arguments in support of these policies have been examined. It is claimed that the pharmacopoeia has a valid regulatory function to perform which is not incompatible with but complementary to that of the registration system.

Chemistry, Pharmaceutical↗
PubMed2004

Collaborative study for establishment of a European Pharmacopoeia Biological Reference Preparation (BRP) for B19 virus DNA testing of plasma pools by nucleic acid amplification technique.

The goal of the collaborative study was to calibrate the B19 DNA content of a candidate Biological Reference Preparation (BRP) that is intended to be used for the validation of the analytical procedure, as threshold control and/or as quantitative reference material in the Nucleic Acid Amplification Technique (NAT) test of plasma pools for detection of B19 contamination. The candidate BRP was calibrated against the 1st International Standard for B19 DNA NAT assays. According to the European Pharmacopoeia monograph Human anti-D immunoglobulin, the threshold control needs to have a titre of 10( 4) IU/ml of B19 virus DNA. The lyophilised candidate BRP was prepared from 0.5 ml aliquots of a plasma pool spiked with B19 virus. The B19 virus originated from a "B19 virus window phase" blood donation (anti-B19 negative, B19-DNA high titre positive) and was diluted in a plasma pool tested negative by both serological and NAT assays for Hepatitis B Virus, Hepatitis C Virus and Human Immunodeficiency Virus 1 to obtain a B19-DNA concentration level in the range of 10( 6) copies/ml. The residual water content of the lyophilised candidate BRP was determined as 0.98 +/- 0.65% (mean +/- relative standard deviation). Sixteen laboratories (Official Medicine Control Laboratories, manufacturers of plasma derivatives, NAT test laboratories and NAT kit manufacturers) from nine countries participated. Participants were requested to test the candidate BRP and the International Standard (99/800) in four independent test runs on different days using their in-house qualitative and/or quantitative NAT methods. Sixteen laboratories reported results. Thirteen laboratories reported results from qualitative assays and 5 laboratories reported results from quantitative assays. Two laboratories reported results from both types of assay. For the qualitative assays a weighted combined potency of 5.64 log( 10) IU/ml with 95 per cent confidence limits of +/- 0.17 log( 10) which corresponds to 67 to 150 per cent of the estimated potency was determined. For the quantitative assay the semi-weighted combination of the 5 potency estimates lead to a combined potency of 5.83 log( 10) IU/ml with 95 per cent confidence limits of +/- 0.04 log( 10) which corresponds to 91 to 110 per cent of the estimated potency. The semi-weighted combination of the results from both types of assay lead to a final potency estimate of 5.80 log( 10) IU/ml with 95 per cent confidence limits of +/- 0.05 log( 10) which corresponds to 86 to 117 per cent of the estimated potency. A threshold control suitable for quantitative testing of B19 DNA and reflecting the requirements of the European Pharmacopoeia monograph Human anti-D immunoglobulin should contain 104 IU/ml of B19 DNA. Taking into account the assigned titre of 5.80 log( 10) IU/ml (630.957 IU/ml), a dilution of 10(-1.8) (1/63) of the candidate BRP should yield a positive response. This concentration was easily detected by all participating laboratories in all tests. The candidate BRP thus appeared to be suitable for the intended purpose. The candidate BRP was adopted as the European Pharmacopoeia BRP by the European Pharmacopoeia Commission at its session in June 2003 and is available from the European Directorate for the Quality of Medicines (Catalogue Number: Y0000285).

DNA, Viral↗
PubMed1986

Reduction of animal usage: British Pharmacopoeia Commission policy.

The British Pharmacopoeia Commission is committed to working towards the replacement or modification, wherever possible, of those assays and tests of the Pharmacopoeia that are performed in vivo and which may involve pain. An alternative or modified method is adopted by the Commission once it has been clearly demonstrated that it offers satisfactory control for pharmacopoeial purposes of the potency or other specific property of the preparation concerned. The relevant monographs of the British Pharmacopoeia and of the British Pharmacopoeia (Veterinary) are kept under active review and number of lines of investigation are being pursued by the appropriate advisory committees in furtherance of the Commission's objective. In vivo techniques are currently required for two main purposes, safety and potency testing of a range of biological materials. The progress being made towards a reduction in animal usage for safety purposes is exemplified by work being carried out with the aim of reducing reliance on rabbit testing for pyrogens. It is expected that the use of HPLC for the assay of peptide hormones may permit the phasing out of certain bioassays. With respect to immunological products several lines of enquiry are being followed. While in vitro alternatives remain the long term objective, the modification of existing in vivo methods to permit non-lethal end-points and the possibility of using analgesics are also considered. In pursuing this policy the Commission actively encourages those associated with its work to seek alternative procedures but it must be understood that the Commission itself has no source of funds to finance the necessary research.(ABSTRACT TRUNCATED AT 250 WORDS)

Analgesics↗
PubMedDate not supplied

Aseptic peritonitis due to peptidoglycan contamination of pharmacopoeia standard dialysis solution.

BACKGROUND: Manufacturers of parenteral solutions adhere to European and US Pharmacopoeia standards to define safety and sterility. In response to excess cases of aseptic peritonitis in peritoneal dialysis patients using icodextrin-containing dialysate that met all pharmacopoeia standards, a global recall was issued in May, 2002. We aimed to establish the cause of aseptic peritonitis. METHODS: We analysed 186 reports of aseptic peritonitis between September, 2001, and January, 2003. Extensive physical, chemical, and microbiological investigations of recalled dialysate were done. We calculated dose-response curves for peptidoglycan-induced interleukin 6 elaboration in peripheral blood mononuclear cells (PBMCs) from healthy donors and for sterile peritonitis in rats. FINDINGS: Although its chemical constituents and concentrations of endotoxin were within pharmacopoeia specifications, the dialysis solution elicited an interlukin 6 response in vivo and in vitro. We identified peptidoglycan from thermophilic acidophilic bacteria (Alicyclobacillus acidocaldarius) as the contaminating proinflammatory substance. In the PBMC assay, strong dose-response relations were noted between peptidoglycan concentrations and interleukin 6. In rats injected with peptidoglycan, dose-dependent increases of intraperitoneal neutrophils and pyrogenic cytokines were recorded. We measured a positive relation between peptidoglycan concentrations in recalled dialysate and reports of aseptic peritonitis. After implementation of corrective actions, the rate of peritonitis returned to baseline. INTERPRETATION: Excess cases of aseptic peritonitis in peritoneal dialysis patients were due to peptidoglycan contamination of dialysate by Alicyclobacillus. This outbreak serves as an example of how contemporary parenteral products with microbial contaminants can be considered safe under current pharmacopoeia tests, but provoke adverse clinical effects.

Animals↗
PubMed1991

Prescription of drugs not listed in a clinic's pharmacopoeia: supervision by clinical pharmacologists.

The pharmaceutical market in the FRG offers about 11,000 different preparations and formulations. A restricted list (pharmacopoeia) containing approximately 1,000 drugs has been proved to cover the routine requirements of a university clinic and most of the additional drugs demanded by the physicians as 'exceptis excipiendis'. Restrictive control of requests for drugs not included in the internal pharmacopoeia by clinical pharmacologists has reduced the absolute number of requests by half, and about 60% of the remaining requests could be replaced by drugs listed in the pharmacopoeia. The majority of the special requests arose from the continuation of drugs presented to out-patients by the resident physicians after admission of the patient to the hospital. The supervision may lead to more critical revision of out-patient medication, but a substantial reduction of drug expenditure was not attained, as the drugs requested amounted only to a minor fraction of the overall drug expenditure by the hospital.

Drug Prescriptions↗
PubMedDate not supplied

[Sources of error in the European Pharmacopoeia assay of halide salts of organic bases by titration with alkali].

A short overview has been given by the authors on the titrimetric assay methods of halide salts of organic bases in the pharmacopoeias of greatest importance. The alternative procedures introduced by the European Pharmacopoeia Commission some years ago to replace the non-aqueous titration with perchloric acid in the presence of mercuric acetate have also been presented and evaluated. The authors investigated the limits of applicability and the sources of systematic errors (bias) of the strongly preferred titration with sodium hydroxide in an alcoholic medium. To assess the bias due to the differences between the results calculated from the two inflexion points of the titration curves and the two real endpoints corresponding to the strong and weak acids, respectively, the mathematical analysis of the titration curve function was carried out. This bias, generally negligible when the pH change near the endpoint of the titration is more than 1 unit, is the function of the concentration, the apparent pK of the analyte and the ionic product of water (ethanol) in the alcohol-water mixtures. Using the validation data gained for the method with the titration of ephedrine hydrochloride the authors analysed the impact of carbon dioxide in the titration medium on the additive and proportional systematic errors of the method. The newly introduced standardisation procedure of the European Pharmacopoeia for the sodium hydroxide titrant to decrease the systematic errors caused by carbon dioxide has also been evaluated.

Carbon Dioxide↗
PubMed1993

The European Pharmacopoeia.

In defining a pharmacopoeia as an instrument for the quality control of medicines in the public health field, the author illustrates the origin, history and development of the European Pharmacopoeia since the Brussels Treaty in 1948. 20 countries are now applying the European Pharmacopoeia standards; they are based on an international Convention, which is a sort of law-making and institutional treaty.

Europe↗
PubMed1975

Information chapters in pharmacopoeias.

Pharmacopoeias have been established by governmental authorities to serve three primary purposes: 1) to compile a select list of currently utilized drugs, including the most efficient forms for their application; 2) to distinguish these articles by convenient and definite names; and 3) to publish objective standards and analytical methods suitable for testing the integrity of commercially available preparations. In addition, some pharmacopoeias also offer informational text intended to instruct pharmacists on the compounding, use, storage and labeling of drugs; to advise physicians about dosage regimens and preferred modes of administration; to counsel producers about good manufacturing practices, and to edify drug analysts by explaining the theories underlying methods employed in compendial tests and assays. Examples of informational chapters in USP XIX are those on Pharmaceutical Dosage Forms, Stability Considerations in Dispensing Practice, and Sterilization. Because of the official status of national pharmacopoeias and their use as regulatory instruments in drug control, pharmacopoeial text intended merely for the information of the reader should be identified as such, and should be separated and distinguished from the mandatory, legally enforceable requirements.

Legislation, Drug↗
PubMed2002

[Certification of suitability of monographs of the European pharmacopoeia].

In April 1994, t he European Pharmacopoeia Commission set up a new procedure for the "Certification of Suitability of Monographs of the European Pharmacopoela" to deal with the changing requirements of the licensing authorities and the growth of international trade, notably as regards raw materials to be used in the manufacture of medicines. This procedure was the result of extensive collaboration between the licensing authorities of the European Union and the other parties to the European Pharmacopoeia Convention, and it enables a manufacturer of a raw material for pharmaceutical use to demonstrate that the purity of their substance is suitably controlled by the monograph of the European Pharmacopoeia; this demonstration is now required by the guideline on "Requirements in Relation to Active Substances" published in Volume 3A of the Rules Governing Medicinal Products in the European Union. Initially set up in response to problems with impurities of synthesis and residual solvents that can vary from one manufacturer to another, the procedure has gradually been extended to a very wide range of products including products of fermentation and, more recently, products with risk of transmitting agents of animal spongiform encephalopathies.

Certification↗
PubMed2004

Establishment of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparations (BRP) batch 2 for rDNA hepatitis B vaccine (method A and B).

A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM), to assign a potency value for candidate batch 2 of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Hepatitis B (rDNA) antigen in vitro assays, for both method A and method B by calibrating them against the Ph. Eur. BRPs, batch 1 for methods A and B respectively. The study was prompted by the observation that the first batch of BRP for method B appeared to have lost potency over time. BRP 1 for method A showed no loss in potency, however stocks of the material were nearing depletion. Eleven laboratories participated in the study and all reported results. Participants performed 3 independent assays using both method A and method B. Method A was used to assess BRPs for method A and method B was used to assess BRPs for method B. Since BRP 1B was suspected to have lost potency, an additional sample was included in the method B test in an attempt to clarify the situation. BRP 1B was also assayed in method A against BRP 1A in the hope of also attaining further information by comparing the results from this study to those obtained in the original study to establish the first batch of BRP [1]. Although it was not the primary aim of this study to correlate in vitro potency with the immunogenicity assay in mice, a number of interested parties also performed the mouse in vivo assay to obtain data on the behaviour of the candidate BRPs in this assay. For method A, potency estimates were satisfactory in terms of repeatability and reproducibility. The candidate material was therefore assigned a value of 16.6 micrograms/ml. For method B, it appeared that the observation of reduced in vitro potency of BRP1 was confirmed. Despite the attempt to clarify the situation with additional studies, it was not possible to assign a potency value with the results obtained. A small-scale collaborative study will be organised to determine an appropriate value for the candidate BRP for method B. The results from the in vivo study while highly variable showed no evidence of a shift in the in vivo potency for either BRP 1A or BRP 1B. It should be noted that the in vitro method for determination of hepatitis B vaccine potency is under revision due to the discontinuation of the Auszyme kit from Abbott, which is required to perform the current assays. Once an alternative assay has been established, the suitability of the reference preparations or establishment of new reference preparations will be required. The candidate material for method A BRP was adopted by the European Pharmacopoeia Commission at its session in November 2003, as the European Pharmacopoeia Hepatitis B vaccine (rDNA) method A, batch 2.

Animals↗
PubMed2004

Collaborative study to establish the Low-molecular-mass heparin for assay--European Pharmacopoeia Biological Reference Preparation.

Thirty laboratories participated in a collaborative study to calibrate replacements for the 1st International Standard for Low Molecular Weight Heparin and the European Pharmacopoeia Low-molecular-mass heparin for assay Biological Reference Preparation. Two freeze-dried materials and one liquid preparation were included in the study. All three samples gave excellent intra- and inter-laboratory variations (majority of mean % geometric coefficient of variation < 10 %) when assayed against the 1st International Standard by both anti-Xa and anti-IIa assays. There were no major differences found between potency estimates using all methods and that obtained using European Pharmacopoeia method only. Overall, this study showed that the differences between the candidates are marginal. Based on the results of the study Sample B, 01/608 was established as the 2nd International Standard for Low Molecular Weight Heparin. Sample A, 01/592 and sample C, the liquid preparation, were established as replacements for the European Pharmacopoeia 'Low-molecular-mass heparin for assay' Biological Reference Preparation.

Calibration↗
PubMed1989

[Study of talc for pharmaceutical use. Trials of pharmacopoeias].

A study has been carried out on the possible pharmaceutical use of spanish talcs following the normalized assays of the main european pharmacopoeia and other quantitative methods. Only the talc nr3, not processed, meets all the assays of pharmacopoeia. The samples 2 and 4 (crushed) exceed the highest tolerated content in chlorides. The talc 1 (also crushed) only meets the loss on drying. The measures of some of these assays by using quantitative methods lead to more correct results and even sometimes in opposition with those obtained by pharmacopoeia methods. The particle size estimated by shifting and sedimentation shows that the crushed talcs are silty, whereas the only talc not processed is sandy. Considering the medium sizes estimated by scanning microscopy, it can be said that the pulverization of the talcs 1, 2 and 4 is characteristic of a micronization.

Particle Size↗
PubMed1985

[The purity testing of drugs and drug preparations according to flexible pharmacopoeia instructions].

It is well known, that the quality standards of the various pharmacopoeias are based on certain procedures of synthesis or preparation concerning the drugs. Altering the manufacturing methods or importing these drugs from different producers, it may arise that the examined substance will formally come up to the quality directions of the pharmacopoeia agreed upon, but will contain possible, critical contaminations which are beyond the pharmacopoeia directions of examinations.

Chemistry, Pharmaceutical↗
PubMed1997

[Chemical tests with Marrubium species. Official data on Marubii herba in Pharmacopoeia Hungarica VII].

About 40 species of the Marrubium genus (Lamiaceae) are known of which 2 species (M. vulgare L. and M. peregrinum L.) and one hybrid (M. x paniculatum Desr.) can be found as native plants in Hungary. The above-ground parts of M. vulgare L. are official in Hungarian Pharmacopoeia VII. Active substances in Marrubii herba are labdane-structured bitter materials. Although the presence of furanic labdane diterpenes in the plant is known, the pharmacopoeia gives only microscopic tests, qualitative tests (for other parts of the plant and foreign organic matter) for the bitter value of Marrubii herba. We have examined the main terpenoid substances isolated with column, gel and preparative layer chromatography. Structure elucidations were performed by means of UV, mass and NMR spectroscopy. We have compared the changes in terpenoid-type compounds (premarrubiin and marrubiin) in plants during the vegetation period; in different Marrubium species and in the different extractions of horehound by means of thin layer chromatography and densitometry. By reason of our results we propose qualitative and quantitative chemical tests for the paragraph of Marrubii herba in Pharmacopoeia Hungarica VII.

Diterpenes↗