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PubMed1996

Alternatives to animal testing: achievements and recent developments in the European Pharmacopoeia.

The European Pharmacopoeia has declared its full support for thorough application of the three Rs in the tests that comprise the official standards. Significant progress has been achieved in the last few years in the fields of pyrogen testing, hormones, blood products and, to a lesser extent, vaccines. Many projects are at present under way. Until recently, the approach was more or less passive, awaiting a consensus on new methods before incorporation into the official standard. However, a more active approach has now been adopted, notably by the organisation of validation exercises both to establish alternative methods and to encourage their wide use. All users of the Pharmacopoeia are concerned by this problem and they should be aware that all proposals and initiatives will be followed up within the means at our disposal.

Animal Testing Alternatives↗

PubMed2002

Calibration of replacement international standard and European pharmacopoeia biological reference preparation for tetanus toxoid, adsorbed.

Here we report the characterisation of a preparation of tetanus toxoid, adsorbed, and its calibration by 27 laboratories in 19 countries in a joint international collaborative study co-sponsored by World Health Organization (WHO) Expert Committee of Biological Standardization (ECBS) and the European Biological Standardisation Programme of European Directorate for the Quality of Medicines (EDQM), Council of Europe. Calibration was in terms of the Second International Standard (I.S.) for Tetanus Toxoid, Adsorbed, by the established WHO/European Pharmacopoeia (Ph Eur) challenge methods. The replacement standard preparation was found to have a unitage of 469 IU/ampoule on the basis of its calibration in guinea-pigs and 496 IU/ampoule on the basis of its calibration in mice. Assessment, both within the collaborative study and as part of candidate characterisation, indicated satisfactory stability of the candidate preparation. This study also provided some information on the effect of mouse strain on potency testing of tetanus vaccines. A limited assessment of the impact of the replacement standard on testing of current production batches of vaccines was also carried out by four manufacturers. This study did not directly address the serological approaches to potency testing. However, one laboratory offered data from mouse serology assay, which gave comparable estimates to in vivo mouse bioassay. Based on the results of this study and with the agreement of participants, the candidate standard was established as the Third International Standard for Tetanus Toxoid, Adsorbed (coded 98/552) by the WHO Expert Committee of Biological Standardization (ECBS) in November 2000. The same preparation was also established as the second Ph Eur Biological Reference Preparation (Ph Eur BRP, batch no. 2) by the Steering Committee of the Biological Standardisation Programme of the EDQM and approved by the European Pharmacopoeia Commission.

Animals↗

PubMed2004

Static headspace gas chromatographic method for quantitative determination of residual solvents in pharmaceutical drug substances according to european pharmacopoeia requirements.

A static headspace (HS) gas chromatographic method for quantitative determination of residual solvents in a drug substance has been developed according to European Pharmacopoeia general procedure. A water-dimethylformamide mixture is proposed as sample solvent to obtain good sensitivity and recovery. The standard addition technique with internal standard quantitation was used for ethanol, tetrahydrofuran and toluene determination. Validation was performed within the requirements of ICH validation guidelines Q2A and Q2B. Selectivity was tested for 36 solvents, and system suitability requirements described in the European Pharmacopoeia were checked. Limits of detection and quantitation, precision, linearity, accuracy, intermediate precision and robustness were determined, and excellent results were obtained.

Chromatography, Gas↗

PubMed1987

The effects of reductions in the numbers of animals used for the potency assay of the diphtheria and tetanus components of adsorbed vaccines by the methods of the European pharmacopoeia.

Forty eight assays of adsorbed diphtheria vaccine and seven assays of adsorbed tetanus vaccine using either a lethal challenge (38 assays) or a serum neutralization test (17 assays) were evaluated for the effects of reductions in the number of animals used at each dilution on the potency values and 95% confidence intervals. The results were assessed in the light of the requirements of the European Pharmacopoeia and the WHO. In the majority of assays, 50% of the number of animals presently required would have sufficed for the determination of a potency within the limits of confidence stipulated by the European Pharmacopoeia and the WHO. Therefore it is concluded that a simplified assay with a reduced number of animals is suitable for the routine potency testing of the diphtheria and tetanus components of the combined vaccines and the monovalent that were examined. Flexibility in the national and international requirements in respect of the numbers of animals used at each dilution is suggested for the routine potency assay of the diphtheria and tetanus components of adsorbed vaccines.

Animal Welfare↗

PubMedDate not supplied

The pediatric cardiology pharmacopoeia: 2004 update.

Seven years ago, Pediatric Cardiology published the first version of a review article outlining the various medications used in the field of heart diseases in children. This article is an update and expansion to what we have previously presented. Therapeutic intervention, both surgical and through cardiac catheterization, has enabled cure and palliation of an increasingly expanding spectrum of diseases at earlier ages and with more complex lesions. Refinement of these procedures includes more advanced tools as well as the support of an expanding armament of pharmacopoeia used to stabilize and support patients before, during, and after such procedures. In addition to updating previously published data regarding inotropes, antiarrhythmics, vasodilators, diuretics, sedatives, and analgesics as well as a variety of miscellaneous medications, this article describes the use of pulmonary medications frequently needed in patients with congestive heart failure, pulmonary edema, and chronic lung disease. We also describe the difficult management of withdrawal as a result of use of sedatives and analgesics. The most recent recommendation for subacute bacterial endocarditis prophylactic antibiotic regimens is also described.

Cardiology↗

PubMedDate not supplied

The pediatric cardiology pharmacopoeia.

Keeping up with a rapidly growing list of medications has always been a breathtaking and, at times, impossible task to master. Contrary to common belief, the enormity of keeping abreast with the more recently developed medications is not a modern phenomenon resulting from the great technological advances of the past few years, but an ongoing struggle spanning the latter half of this century. It appears that there are more drugs to use than to know how, when, or what to do with them. This sentiment was expressed in 1973 by the editors of Martindale's The Extra Pharmacopoeia, twenty-sixth edition [3]: "The unprecedented rate at which our knowledge of medicine and pharmacy is advancing makes it a formidable challenge to provide within a single volume an up-to-date source of basic information on the properties and uses of the many drugs in current use." In this article, a review of the medications currently used in the management of children with heart diseases is presented. The medications have been collected in groups based upon their pharmacological actions: Antiarrhythmic, antihypertensive, diuretics, sedatives and miscellaneous agents. Within each group the agents are listed alphabetically using chemical names. We attempted to include as many drugs as thought to be of relevance to the team of health practitioners involved in the care of children with cardiac problems. Various routes of administration are presented, some of which have been infrequently described in the pediatric literature, such as continuous infusion of diuretic agents [22]. The dosing ranges were adopted from many sources [1, 5, 8, 9, 17-19, 22, 23, 26], and we sought to include the widest ranges of dosages published. All dosages listed in Table 1 are quantitated per dose and not per day. This approach was adopted as it reduces calculations and the potential for medication errors.

Adolescent↗

PubMed1981

A Hausa herbal pharmacopoeia: biomedical evaluation of commonly used plant medicines.

Biochemical analysis of a selected sample of the Hausa (northern Nigeria) medicinal flora is presented in order to assess potential chemotherapeutic values. Laboratory investigation, supplemented by previously published phytochemical constituent analyses of pertinent taxa, suggests that a number of disorders can be effectively treated by the Hausa practitioner. The Hausa herbal pharmacopoeia is analysed first with reference to its efficacy in the treatment of oral disease. Examined subsequently are Hausa plant medicines considered to be of potential value in the treatment and/or prevention of malaria infection, with particular attention focussed on the malaria symptom complex and parasite-host cell biochemistry. Results are discussed in the context of the adaptive potential of non-Western medical systems and the significance of this aspect for medical policy development programs.

Drug Evaluation, Preclinical↗

PubMed1991

Merging pharmacopoeia: understanding the historical origins of incorporative pharmacopoeial processes among Xhosa healers in southern Africa.

This paper focusses on Xhosa healers and their pharmacopoeias in Southern Africa. Its preliminary aim is to show that Xhosa healers have incorporated Western pharmaceutical products into their traditional dispensaries. The primary aim of the paper is to explain the trend towards medicinal incorporation in terms of the historical development of health and health care in Xhosa-speaking regions. Finally, it is suggested that Xhosa healers utilise Western medicines for their symbolic value, allowing them to negotiate some of the historical precedents which have had the effect of marginalising their profession.

Africa, Southern↗

PubMed1991

Phytochemical screening of a Warao pharmacopoeia employed to treat gastrointestinal disorders.

A three-year medical-ethnobotanical investigation among the Warao of the Orinoco Delta in eastern Venezuela documented a pharmacopoeia of 100 plant species representing 45 families. Warao phytotherapists manipulate these plants in diverse manners to produce 259 remedies of various complexities to treat 52 classes of diseases/disorders. National health statistics indicate that gastrointestinal disease ranks as a principal cause of morbidity and mortality in this part of the country. Ten plant species, specifically employed by the Indians against these disorders, were subjected to phytochemical screening. Test results are listed together with the ethnoepidemiological protocol that governs the selection and administration of these medicinal plants in Warao society.

Gastrointestinal Agents↗

PubMed2006

Evaluation of an International Pharmacopoeia method for the analysis of nelfinavir mesilate by liquid chromatography.

A gradient LC method for the determination of related substances in nelfinavir mesilate (NFVM) has been recently published in the International Pharmacopoeia. The method uses a base deactivated reversed phase C18 column (25 cm x 4.6 mm I.D.), 5 microm kept at a temperature of 35 degrees C. The mobile phases consist of acetonitrile, methanol, phosphate buffer pH 3.4 and water. The flow rate is 1.0 ml/min. UV detection is performed at 225 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards NFVM components was investigated on 18 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm I.D.), 5 microm. A two level fractional factorial design was applied to examine the robustness of the method. The method shows good selectivity, precision, linearity and sensitivity. Seven commercial samples were examined using this method.

Chromatography, Liquid↗

PubMed2006

Electrochemical detection of tobramycin or gentamicin according to the European Pharmacopoeia analytical method.

Tobramycin and gentamicin are two aminoglycosidic antibiotics used in lung infection, ophthalmic treatments as well as in skin infections. Pharmaceutical companies which produce remedies containing tobramycin and gentamicin need an analytical method for their internal quality control. For several years a simple chromatographic method based on anion exchange separation coupled with amperometric detection was proposed for aminoglycosides. This analytical approach was partially used in the last edition of the European Pharmacopoeia (EP) for tobramycin and gentamicin analysis. In fact they use integrated pulsed amperometric detection (IPAD) on a gold electrode while the separation is obtained on a polymeric wide pore reversed phase instead of anion exchange in alkaline conditions. Such coupling seems to be cumbersome and not so easy to realize and to reproduce from one laboratory to another. Besides, the described method lacks some of the details as important as the waveform steps duration. Unfortunately the quality control (QC) laboratories have to use exactly the method described in the EP, so they complained about the troubles. Therefore, the EP authors published recently a paper regarding the guidelines for good practice in the method application, but the suggestion was not yet resolutive. In our work we evaluated the eluent composition and the kind of amperometric cell, work electrode diameter and cell volume. Mainly we optimized the amperometric waveform. In addition, for tobramycin analysis another chromatographic phase was explored in order to achieve better efficiency and to separate all the impurities confirming the effectiveness of the detection. The conditions described in the paper seem to allow the analyst to operate in conformity with the EP method.

Aminoglycosides↗

PubMed2005

Traditional pharmacopoeias and medicines among Albanians and Italians in southern Italy: a comparison.

A cross-cultural comparison of traditional household remedies in primary health care and ritual healing practices in two economically and socio-demographically similar communities in Lucania (inland southern Italy) was considered: Ginestra/Zhurë, inhabited by ethnic Albanians, who migrated to the area during the 15th century, and Castelmezzano, inhabited by autochthonous South-Italians. In Ginestra/Zhurë, the number of traditional natural remedies (mainly derived from local medicinal plants) was only half of that in the local folk pharmacopoeia quoted in Castelmezzano. However, ritual magic-healing practices still play a central role among the Albanians in Ginestra/Zhurë, while they do not in Castelmezzano. Reasons for this shift, as well as components that have affected cultural adaptation phenomena and transitions among the Albanians are discussed.

Albania↗

PubMed2006

Traditional medicine in Central Sahara: pharmacopoeia of Tassili N'ajjer.

Further to the previously reported ethnobotanical surveys of North-Sahara and Ahaggar [Maiza, K., Brac de la Perrière, R.A., Bounaga, N., Hammiche, V., 1990. Usages traditionnels des plantes spontanées d'El Goléa. Actes du Colloque de l'Association. Française pour la Conservation des Espèces Végétales, Mulhouse; Maiza, K., Hammiche, V, Bounaga, N., Brac de la Perrière, R.A., 1992. Inventaire des plantes médicinales de trois régions d'Algérie. Actes du Colloque International hommage à Jean Pernès: Complexes d'espèces, flux de gènes, ressources génétiques des plantes. Paris, pp. 631-633; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1993a. Traditional Saharian pharmacopoeia. Acta Horticulturae, I.S.H.S. 332, 37-42; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1993b. Récents apports à l'ethnopharmacologie du Sahara algérien: Actes du 2ème Colloque Européen d'Ethnopharmacologie & 11ème Conférence Internationale d'Ethnomédecine. Heidelberg, pp. 169-171; Maiza, K., Brac de la Perrière, R.A., Hammiche, V., 1995. Pharmacopée traditionnelle saharienne. Revue de Médecines et Pharmacopées Africaines, 9 (No. 1), 71-75; Maiza, K., Smati, D., Brac de la Perrière, R.A., et Hammiche, V., 2005. Pharmacopée traditionnelle au Sahara Central: Pharmacopée de l'Ahaggar. Retenu pour publication. Revue de Médecines et Pharmacopées Africaines.], we have now moved our investigations on Tassili N'Ajjer, another distinct region of the Southern Algerian Sahara. Ethnobotanic research has been carried out through interviews with nomad populations and the traditional pratictionners of recognised competence. To date, 80 wild indigenous medicinal plants have been identified and are currently used by the local population for various illnesses. Information on their vernacular Tamahaq and Arabic names, their flowering distribution, the parts used, the modes of preparation and routes of administration are reported and discussed in this paper. This work completes our investigation in Central Sahara.

Africa, Northern↗

PubMed2006

Mexican migrant ethnopharmacology: pharmacopoeia, classification of medicines and explanations of efficacy.

This paper describes the ethnopharmacological knowledge of women in an urban Mexican migrant community in Athens, GA, USA. Data were collected using free-list, pile-sort and semi-structured interviews. The pharmacopoeia of this community includes herbal remedies, over-the-counter medications such as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription medicines. Multi-dimensional scaling analysis of pile-sort data revealed that Mexican women living in Athens classify medicines into four categories: herbal remedies, salves, pastillas (pills-both prescription and non-prescription) and other commercial preparations. Herbal remedies are viewed as natural and safe while pastillas are thought to be dangerous and potentially addictive. Comparisons of Mexican explanations for the actions of five medicines (Matricaria recutita L. [Asteraceae], Mentha spp. L. [Lamiaceae], Ruta spp. L. [Rutaceae], Ocimum basilicum L. [Lamiaceae] and paracetemol) with the pharmacological literature show several similarities and confirm that migrant women use these medicines effectively. Mexican migrant women use medicinal plants in combination with commercially produced medicines, but most have a strong preference for the herbal remedies that they make themselves, over drugs prescribed by physicians. Some of their descriptions of the actions of medicines are supported by the pharmacological literature, but ethnopharmacologists have not fully investigated all of the attributes that migrant women ascribe to them.

Attitude to Health↗

PubMed2004

Ruggedness/robustness evaluation and system suitability test on United States Pharmacopoeia XXVI assay ginsenosides in Asian and American ginseng by high-performance liquid chromatography.

The work of the ruggedness/robustness evaluation and system suitability tests was oriented to profound understand the practicability of using assay methods issued by United States Pharmacopoeia (USP XXVI and XXVII) for ginsenosides in Asian ginseng and American ginseng. The items chosen for the method validation included quantitative related items such as recovery of Rg(1) and Rb(1), respectively, and qualitative related items such as resolution, theoretical plate number, relative retention time of two critical-band-pairs, Rg(1)/Re and Rb(1) with its neighboring peak, respectively. Totally, 16 column types were used for comparison of different vendors, different packing materials, different size, etc. and five sets of LC systems and two laboratories were involved in comparing the data of both quantitative and qualitative items. The results showed that different packing materials of columns used might significantly alters separation. The column packing material Hypersil afforded the preferable separating for the ginsenosides. No significant difference was observed from the different instrumentations and inter-laboratories. Our results suggest a modification of the system suitability test as given in USP26-NF21 and the latest version of USP27-NF22, which was not suitable for most systems. Using resolutions of Rg(1)/Re and Rb(1) with its neighboring peak as critical parameters for the ginsenosides assay and omitting the relative retention time of both Rg(1)/Re and Rb(1) with its neighboring peak is our suggestion for a more reasonable, yet practicable system suitability. Six typical chromatograms gain from different columns were figured out as well.

Asia↗

PubMed2006

Evaluation of an International Pharmacopoeia method for the analysis of indinavir sulfate by liquid chromatography.

A gradient LC method for the determination of indinavir sulfate (IDV) and its impurities has been recently published in a consultation document of the International Pharmacopoeia, WHO Drug Information. The method uses a base-deactivated reversed-phase C18 column (25 cm x 4.6 mm i.d.), 5 microm kept at a temperature of 40 degrees C. The mobile phases consist of acetonitrile, phosphate buffer pH 7.5 and water. The flow rate is 1.0 ml/min. UV detection is performed at 220 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards IDV components was investigated on 16 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm i.d.), 5 microm. A central composite design was applied to examine the robustness of the method. The method shows good precision, linearity, sensitivity and robustness. Six commercial samples were examined using this method.

Chromatography, Liquid↗

PubMed2006

Evaluation of an International Pharmacopoeia method for the analysis of saquinavir (mesilate) bulk drugs by liquid chromatography.

A single gradient LC method for the determination of related substances in both saquinavir (SQV), saquinavir mesilate (SQVM) has been published in a consultation document of the International Pharmacopoeia, WHO Drug Information. The method uses a base deactivated reversed phase C18 column (25 cm x 4.6 mm i.d.), 5 microm kept at a temperature of 30 degrees C. The mobile phases consist of acetonitrile, methanol, phosphate buffer pH 3.4 and water. The flow rate is 1.0 ml/min. UV detection is performed at 220 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards SQV(M) components was investigated on 18 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm i.d.), 5 microm. A central composite design was applied to examine the robustness of the method. The method shows good precision, linearity, sensitivity and robustness. SQV(M) commercial samples of bulk drugs were examined using this method.

Algorithms↗

PubMedDate not supplied

Quality control of aromatic drugs reported in European Pharmacopoeia 3rd edition.

The apparent current explosion of interest and commercial activity in the area of herbal products should be followed by accurate quality control. In this work, the authors carried out the specific quality assays of all the aromatic drugs reported in European Pharmacopoeia. For each drug, several samples of different brands were bought in pharmacies, herbalist's shops, or supermarkets. The worst results were obtained in the assay for the essential oil content and this is very negative as the medicinal activities of these drugs are ascribed to their essential oil content. The samples of different brands yielded very different results from a qualitative point of view. In most cases, the analyzed samples were very far from the acceptable qualitative standards that they definitely lacked any health benefits.

Europe↗