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PubMed2002

Two-dimensional electrophoresis of recombinant human erythropoietin: a future method for the European Pharmacopoeia?

Quality assurance of recombinant protein drugs concerning identity and purity represents a difficult task, in particular, when post-translational modifications lead to a heterogeneous mixture of biomolecules. We chose Neorecormon (rh-EPO, Roche) for our studies to demonstrate the efficiency of two-dimensional electrophoresis (2-DE) to analyse post-translationally modified recombinant drugs. More than 40 protein spots in the range from isoelectric point (pI) 3.5-4.5 and 32-45 kDa could be separated. Enzymatic deglycosylation revealed that the heterogeneity of the protein pattern is mainly caused by variations in glycosylation. In comparison to the separately performed isoelectric focusing and sodium dodecyl sulfate-polyacrylamide gel electrophoresis, as requested by the European Pharmacopoeia, we see a great synergy to use 2-DE for the analysis of rh-EPO. A by far higher resolution can be achieved, allowing an improved differentiation of the various rh-EPO glycoforms. Sequential deglycosylation of sialic acids, N-glycosides and the O-glycoside lead to significant shifts both in apparent relative molecular mass and pI. Comparing the 2-DE patterns of rh-EPO before and after deglycosylation allows on the one hand valuable information to be gained on the glycosylation of the recombinant protein and shows on the other hand how significantly the 2-DE protein pattern can be influenced by the glycosylation. As the equipment for the performance of 2-DE has improved significantly over the last decade, we see 2-DE as a reliable method, which should be approved for the routine quality assurance of recombinant drugs and also recommended for the European Pharmacopoeia.

Amino Acid Sequence↗

PubMed2001

Calibration of replacement international standard and European Pharmacopoeia Biological Reference Preparation for Diphtheria Toxoid, Adsorbed.

We report here the characterisation of a preparation of diphtheria toxoid, adsorbed, and its calibration by twenty laboratories in fourteen countries in terms of the Second International Standard (I.S.) for Diphtheria Toxoid, Adsorbed, coded sample A (DIXA) using the established World Health Organisation (WHO)/European Pharmacopoeia (Ph Eur) challenge methods. The replacement standard preparation was found to have a unitage of 160 IU/ampoule on the basis of its calibration by in vivo bioassay. Stability was assessed within the collaborative study, and as part of candidate characterisation. Results suggest that the replacement standard will have satisfactory stability. This study also provided an opportunity to investigate serology as alternative to in vivo bioassay for potency testing of diphtheria vaccines. Six laboratories participated by performing serology according to in-house protocol. The calibration of the replacement standard in a mouse Vero cell assay gave a significantly higher results than in the established WHO/Ph Eur methods. Based on the results of this study and with the agreement of participants, the candidate standard was established as the Third International Standard for Diphtheria Toxoid, Adsorbed (coded 98/560) by the WHO Expert Committee of Biological Standardization in October 1999. The same preparation was also established as the second Ph Eur Biological Reference Preparation (Ph Eur BRP, batch no. 3) by the Steering Committee of the Biological Standardisation Programme of the European Directorate for the Quality of Medicines and approved by the European Pharmacopoeia Commission.

Adsorption↗

PubMed1983

[Chromatographic determination of ointment bases and emulsifying agents in European and German pharmacopoeias].

The ointment bases Lanolinum, Lanae alcoholum unguentum, Zinci unguentum, Polyethylenglycoli unguentum, Unguentum leniens and Unguentum emulsificans, and the emulsifying agents Glyceroli monostearas, Polyethylenglycoli 400 stearas and Polysorbatum 20, 60, 80 were identified by HPTLC and their most important components were determined quantitatively by application of HPLC. The proposed methods of identification are more specific than those described in the monographs of the pharmacopoeias. The obtained results were compared with the nominal values listed in both pharmacopoeias as assays of these bases and emulsifiers are not mentioned, except for glyceroli monostearas.

Chromatography, High Pressure Liquid↗

PubMed2006

[The pharmacopoeia. An important pillar of drug safety].

The pharmacopoeia is an official collection of approved pharmaceutical standards. In addressing anyone who produces, distributes or controls medicinal products it comprises requirements on the quality of medicinal products and of the substances used to manufacture them. Moreover, it provides quality control methods. It is therefore an important component of the drug safety system and thus an instrument for patient and consumer protection. How ever, the trend to outsource the production of raw materials to countries outside Europe is often associated with altered production procedures and may have severe consequences. Unwanted side effects of medicinal products--caused by quality changes of the raw materials--may occur. However, this peril can be significantly reduced by consistently adapting the provisions of the pharmacopoeia to the evolution of the drug market.

Drug Contamination↗

PubMed1983

The occurrence of phthalic acid esters in various samples of commercially available sodium chloride injections (Indian Pharmacopoeia).

Conclusive evidence for the presence of di(2-ethylhexyl) phthalate (DEHP) in 15 out of 17 commercially available sodium chloride injection (Indian Pharmacopoeia) samples was obtained and concentration levels as high as 11.0 mg/500 ml of saline were detected. The presence of such contaminants in i.v. fluids, avoidable by the institution of appropriate quality control measures before manufacturing and marketing, is a matter of serious concern. Stipulated specifications in different pharmacopoeias are meant only to ensure sterility and pyrogenicity, and it is advisable that cognisance be taken of the presence of toxic contaminants e.g. di(2-ethylhexyl) phthalate.

Diethylhexyl Phthalate↗

PubMed1984

Pharmacopoeia of traditional medicine in Venda.

Many researchers in different parts of the world are actively involved in recording the available information on traditional medicine. To contribute to this vast task, we chose Venda, one of the more remote tribes in Southern Africa. We found traditional healing to be very much alive and functioning in this area. Within 2 years of research, we could tabulate 151 medicinal plants with their galenics. Many of the plants listed were frequently used by different healers to treat the same ailment which might substantiate their reliability. On the other hand, certain plants were employed for various indications. Moreover, although the toxic effects of some plants are not included in our list, they are encountered by the Western medical doctors. Therefore, the benefits of compiling such lists on medicinal uses of different plants are twofold. To gain from the positive aspects of the traditional medicine and to eradicate, if possible, the harmful effects of some plants used by the traditional healers. However, during our study, it became clear that the plants used were with some exceptions mainly found in the vicinity of the habitat of the healer or the herbalist. It would therefore be useless to compile a more general pharmacopoeia for the African traditional healing as many of the useful plants in one area cannot be found in another. Hence, a more specific pharmacopoeia for each area would be necessary.

Africa, Southern↗

PubMed1978

The development of British pharmacopoeia monographs for idoxuridine and idoxuridine eye drops using high-pressure liquid chromatography for assay and for controlling related impurities.

The monograph published in the 1973 edition of the British Pharmacopoeia (BP) for idoxuridine required revision because it contained a non-specific assay and no tests for related impurities. It was also necessary to prepare a new monograph for idoxuridine eye drops. The Japanese Pharmacopoeia contains a thin-layer chromatographic test for impurities but this was not considered ideal. Improved thin-layer chromatographic tests were sought but when this was unsuccessful, methods using high-pressure liquid chromatography were examined. A system using reversed-phase chromatography was selected for inclusion in BP Addendum 1977 since it provided a specific assay method and limit test for related impurities which could be applied to both the drug substance and the eye drops.

Chromatography↗

PubMed2006

Are extraction methods in quantitative assays of pharmacopoeia monographs exhaustive? A comparison with pressurized liquid extraction.

The extraction methods in selected monographs of the European and the Swiss Pharmacopoeia were compared to pressurized liquid extraction (PLE) with respect to the yield of constituents to be dosed in the quantitative assay for the respective herbal drugs. The study included five drugs, Belladonnae folium, Colae semen, Boldo folium, Tanaceti herba and Agni casti fructus. They were selected to cover different classes of compounds to be analyzed and different extraction methods to be used according to the monographs. Extraction protocols for PLE were optimized by varying the solvents and number of extraction cycles. In PLE, yields > 97 % of extractable analytes were typically achieved with two extraction cycles. For alkaloid-containing drugs, the addition of ammonia prior to extraction significantly increased the yield and reduced the number of extraction cycles required for exhaustive extraction. PLE was in all cases superior to the extraction protocol of the pharmacopoeia monographs (taken as 100 %), with differences ranging from 108 % in case of parthenolide in Tanaceti herba to 343 % in case of alkaloids in Boldo folium.

Aporphines↗

PubMed2001

Commercially available folic acid supplements and their compliance with the British Pharmacopoeia test for dissolution.

A recent report suggested that some folic acid preparations available in the United States failed to meet the specifications for dissolution specified by the US Pharmacopoeia (USP), of 70 per cent drug release in the first hour of testing. The Teratology Society recommends that women of childbearing age should take a daily supplement of 400 microg folic acid when they are trying to conceive, to reduce the risk of foetal neural tube defects. The consequence of this failure to meet the USP requirements may be that an inadequate dose of folate may be absorbed and thus the expected level of protection against neural tube defects not afforded. The purpose of the present study was to examine a number of brands of folic acid (400 microg), available commercially in the United Kingdom, for compliance with the British Pharmacopoeia (BP) test for dissolution. Ten tablets (or capsules) from each of 11 brands were tested using dissolution apparatus compliant with BP requirements, using 0.1 M sodium hydroxide as the dissolution medium. The results indicated that four of the brands failed to release 70 per cent of the nominal drug content in the first hour of test and thus did not comply with the test. Two of the seven brands that passed the test went on to release more than 150 per cent of the nominal 400 microg drug content. These results highlight the problems of dose uniformity and the potential health risks of slow dissolution and under-dosing in commercially available folic acid dosage forms.

Absorption↗

PubMed1994

[The development of modern Japanese pharmaceutical industry (Part 4). From 1906 to 1920, coinciding with the era between the institution and issue of Japanese Pharmacopoeia Third Edition with Fourth Edition (JP III-JP IV)].

The publishing of the Third Edition of Japanese Pharmacopoeia was performed after Russo-Japanese War, on July 2, 1906. In those times, the military and economical power of Japan advanced toward East Asia, and thus gradually, Japan had become one of the powerful force in the world, partly because due to the unexpected victory in the War. Thereafter, in the second decade of the twentieth century, Japan was involved in the World War I, from July, 1914 to November, 1918, which ceased the fire by the defeat of Germanic Allied Countries. In Japan, the next revise of the pharmacopoeia was performed and the Fourth Edition of it was published on December 15, 1920. The Japanese pharmaceutical industry developed remarkably in those times, during the big war and confusion in the market, by accompanying with the suitable and tentative pharmaceutical legislations by the government and the supportive aids to the civilian enterprises in the productions, supplies and distributions of the materials and medicinal products.

Drug Industry↗

PubMed1993

The influence of Prussian drug legislation on the first German Pharmacopoeia 1872.

When the new Kaiserreich was proclaimed (1871) new rules were stated to organize all the 20 states. A unified Pharmacopoeia was also created. A committee was constituted by the Federal Parliament and the first edition was published in 1872, and in the revised form (editio altera) in 1882, the first one was the continuation of the series of Prussian Pharmacopoeia editions (1799-1862) which resolved many problems concerning the uniformity of weights and measurements, language, analytical assays and prescriptions.

Germany↗

PubMed2001

[Electroanalytical methods in the European pharmacopoeia].

A brief survey on the electroanalytical test methods applied by the European Pharmacopoeia is presented by the authors. The frequency of the use of electrochemical tests and the main fields of their application in the monographs together with the trends of development are discussed. Paying a special attention to the measures taken by the pharmacopoeia to reduce the systematic and random error in each type of measurements, the authors are analysing the content and characteristics of texts describing the electrochemical methods. System suitability tests included in the different procedures and their efficacy in ensuring the criteria established in the validation studies carried out during elaboration of the test methods are also shown.

Electrochemistry↗

PubMed2001

[The National Pharmacopoeia and the therapeutic status of flora in Mexican biomedicine].

The paper analyses the transformation of the Mexican pharmacopoeia, focusing on the presence of medicinal plants. Reflecting diverse processes, editions of the pharmacopoeia show a progressive modification in its content and profile. A text written to shape a Mexican materia medica, recognising empirical knowledge by the inclusion of popularly used resources and involving clinicians as authors and recipients, was transformed into a mainly industrial publication with no clinical references. The origin and implications of this process are explored.

History, 20th Century↗

PubMed2002

Establishment of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for hepatitis A vaccine type B (Aventis Pasteur) batch 2.

A collaborative study was organised by the European Directorate for the Quality of Medicines with the goal to calibrate a candidate European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for hepatitis A vaccine (adsorbed, inactivated) type B (Aventis Pasteur) batch 2 against the International Standard using the antigen content- and immunogenicity assay. Nine laboratories participated in the study; seven carried out both assays. Three samples were to be assayed, sample A, the 1st International Standard for hepatitis A vaccine (inactivated), sample B, the candidate BRP and sample C, the hepatitis A vaccine BRP type B (Aventis Pasteur) batch 1. Samples B and C represent the currently marketed vaccine and contain an antigen that is formalin inactivated and alum adjuvanted. For samples B and C, desorption was necessary prior to the antigen content assay; a proprietary desorption procedure had to be used. Due to an insufficient number of samples, sample C could only be tested in the antigen content assay. Samples A and B had to be tested in 3 independent experiments in the immunogenicity assay; an assay had to be used that produced a dose response curve. All three samples had to be tested also in three independent experiments in the antigen content assay using a standard method. The results from the immunogenicity assays were submitted to probit analyses, the results from the antigen content assays to parallel line analyses on log transformed responses. Based on the results of the collaborative study, the candidate BRP batch 2 appeared suitable as reference preparation for the immunogenicity assay of adsorbed, inactivated hepatitis A vaccines from Aventis Pasteur. A potency value of 262 IU/ml was assigned based on the calibration against the 1st International Standard. The attempt to reproduce the in vitro potency of the BRP batch 1 in the current study failed; only about 50% of the previously established potency was found. It was hypothesised that this loss in potency might be due to ageing of the antigen which changed adsorption behaviour, and subsequently would lead to reduced desorption and lower in vitro potency. Additional experiments were performed to investigate this hypothesis. For older vaccines a much lower degree of desorption and thus a much lower in vitro potency was found, when using the proprietary desorption method. With more vigorous desorption procedures, this problem could only partly be overcome. Thus the results obtained in the antigen content assay in the collaborative study and in the additional experiments did not allow proposing the candidate reference preparation for use in the antigen content assay for hepatitis A vaccine from Aventis Pasteur. The candidate BRP was adopted by the European Pharmacopoeia Commission at its session in March 2002 as Ph. Eur. BRP for hepatitis A vaccine (adsorbed, inactivated) type B (Aventis Pasteur) batch 2 to be used for the immunogenicity assay.

Europe↗

PubMed2003

Establishment of European Pharmacopoeia BRP batch 2 for inactivated poliomyelitis vaccine for in vitro D antigen assay.

A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM) to assign a potency value for the candidate Ph Eur BRP batch 2 against the 2nd International Standard (IS) in order to replace the dwindling stocks of Ph Eur BRP batch 1. The candidate material is a concentrated trivalent bulk (Type 1 (Mahoney), Type 2 (MEF1) and Type 3 (SAUKETT)) from a commercially available IPV vaccine. Nine laboratories participated in the collaborative study. Eight laboratories reported results. Participants performed in-house ELISA assays on the candidate BRP, the 2nd International Standard (IS) and the current BRP (BRP batch 1). An additional sample was included to acquire information on the correlation between the in vitro and in vivo assays based on comparison with a previous study. Results of that comparison are included as an annex. Potency estimates were satisfactory in terms of repeatability and reproducibility, however the estimates for the 2nd IS were significantly lower than those for Ph Eur BRP batch 1. These two reference standards are derived from the same material and were originally assigned the same potency value after a joint study run by EDQM and the WHO in 1994. A reconciliation study was therefore designed to determine if the IS stored at NIBSC and the IS which had been sent from NIBSC to EDQM for use in the initial study were equivalent. 3 of the laboratories from the initial study participated. Results revealed no significant difference between the 2nd IS stocks stored in the two different locations at NIBSC nor between BRP batch 1 and the standards stored at NIBSC for types 1 and 2. For type 3 the 2nd IS standards stored at NIBSC are 13 % less potent than the Ph Eur BRP batch 1. The 2nd IS which had been shipped from NIBSC to EDQM was significantly less potent than BRP batch 1 and the 2nd ISs stored at NIBSC for all three types, confirming the observation of the initial study. Possible explanations for this apparent loss of potency of the 2nd IS used in the study are under investigation. Since Ph Eur BRP batch 1 and the 2nd IS in stock at NIBSC appear no more different than when their original potency assignment was made at their establishment, and since the 2nd IS standard used in the initial part of this study was compromised, a consensus potency value for the candidate BRP was determined using Ph Eur BRP batch 1 as the reference standard. The candidate material was therefore assigned a potency of 320-67-282 D Antigen units/ml (IU) for types 1, 2 and 3 respectively. A stability monitoring program will be initiated. The candidate material was adopted by the European Pharmacopoeia Commission at its session in March 2003 as European Pharmacopoeia IPV vaccine BRP batch 2 for D Ag in vitro assay.

Animals↗

PubMed2004

[Animal experiments in the context of quality control of pharmaceuticals. Review of the European Pharmacopoeia, 4th edition, 2002].

In the 4th edition of the European Pharmacopoeia, animal experiments are described, which are required for the quality control of pharmaceuticals. This refers to investigations regarding both biological activity and safety aspects of the medication. The latter include investigations to find contaminations with histamine and pyrogenic substances and tests for abnormal toxicity. Even though the safety of medical drugs is of great importance, it should be examined whether these tests are still indispensable (in terms of paragraph sign 7 of the German Animal Protection Law of 2002). The determination of histamine content may also be possible by chemical-analytical methods, which could represent an alternative to the animal experiment. The testing of abnormal toxicity should be scientifically questioned due to its lack of specificity. Although the in vitro test detecting bacterial endotoxins is mentioned in many monographs, the in vivo test on rabbits to test for pyrogenicity is still mentioned in some other monographs. The in vivo test should be rechallenged as to whether it can be replaced. In light of the global trade in pharmaceuticals, which must also fulfill national quality standards a reduction in animal experiments can only be reached by fruitful cooperation between pharmaceutical companies, health authorities and the commissions of the pharmacopoeias, leading to the formation of a consensus. The International Conference on Harmonization could prove an auspicious panel to take up this subject and to contribute to an internationally accepted and scientifically based reduction of animal experiments.

Animal Testing Alternatives↗

PubMed1989

[The GDR pharmacopoeia--present situation and outlook with special consideration of quality control].

The Pharmacopoeia of the GDR was published in 1964 and 1975 in its 1st and 2nd edition and, since 1983, has been subjected to another complete revision published in three installments so far. By including monographs for newly registered drugs and modern determination methods as well as by qualifying purity tests and by regulations flexible in their application, the provisions--also in the context of the CMEA Pharmacopoeia--were continuously adapted to developments in the field of drug therapy and to international requirements.

Germany, East↗

PubMed1994

Applicability of diffusion methods required by the pharmacopoeias for testing antibacterial activity of natural compounds.

The diffusion methods required by various pharmacopoeias were investigated in comparison to the bioautographic TLC assay in regard to the applicability and the statistical evaluation for testing the antibacterial activity of natural substances. Naringenin as an example for a weakly effective lipophilic natural compound and tetracycline as standard were used. Data were analysed by linear regression and ANOVA. The comparison of the disk diffusion method, the hole-plate diffusion method, and the bioautographic TLC assay showed that nature and amount of substance influence to a great extent the selection of the test method. The evaluation of parallelism demanded by the pharmacopoeias may provoke problems in comparing natural substances with strongly effective antibiotics. The simultaneous influence of different variables was examined with the help of ANOVA. The bioautographic TLC assay showed for spotted compounds a comparable reproducibility and accuracy to the diffusion methods mentioned above.

Analysis of Variance↗