Role of the list of standard terms in the European Pharmacopoeia for the establishment of the different existing pharmaceutical forms

The type and content of pharmacopoeias have changed many times over the years, until in 1964 the first European Pharmacopoeia was introduced under the jurisdiction of the Council of Europe as part of the implementation of the Convention on the Development of a European Pharmacopoeia.An important section of the European Pharmacopoeia is the list of standard terms. It is drawn up by the Commission of the European Pharmacopoeia, which is part of the European Directorate for the Quality of Medicines and Healthcare (EDQM), at the request of the European Commission, to be used in applications and marketing authorizations and packaging information, in the package leaflet, in the summary of product characteristics and in electronic communications.The main purpose of the study is to make a detailed analysis of the List of Standard Terms available in Bulgarian, as well as the database of standard terms maintained by the European Directorate for the Quality of Medicines in order to make a comparison between them and to identify the most the common dosage forms in them as well as the most common routes of administration.The results of the study show that the largest number are the standard terms referring to medicinal products intended for oral administration and injection. And the most common terms for dosage forms are those for solutions and powders. We also found that the most complete and up-to-date source of information on standard terms for medical devices is the database of standard terms maintained by the European Directorate for the Quality of Medicines, as it is constantly updated. Based on these facts, we can say that the European database is the gold standard for compiling lists of standard terms in each Member State of the Commission of the European Pharmacopoeia. The Bulgarian list of standard terms, on the other hand, is not updated often enough, it is recommended that this be done at shorter intervals, as new terms are constantly appearing. This is best done with each release of an updated version of the pharmacopoeia

Counterfeit medicines

The counterfeiting of medicinal products is a growing concern for patients, the pharmaceutical industry and national policy-makers worldwide. EU internal market rules for medicinal products for human use coupled by wide-ranging International cooperation, and proposed European legislative reforms are hoped to have a positive impact against the problem of counterfeit medicines - one of the greatest current threats to public health and safety.peer-reviewe

Near Infrared Spectroscopy: Applications In Pharmaceutical Industry

This work explores the comprehensive development of a near infrared (NIR) spectroscopic analytical technique for high-throughput applications for the determination of pharmaceutical raw materials and excipients in a pharmaceutical formulation. Advancements in the NIR spectrometry as quality and process control tool have been discussed. The applications include analyses of different types of samples, manufacturing and identification of active pharmaceutical ingredients based on specified experimental design. The samples were measured in diffusion or reflectance mode in a fourier-transform NIR spectrometer. Additionally, chemometric software was employed for quantitative interpretation of bands. The spectrometry can be utilized for identification of raw materials, their size, polymorphism and blend homogeneity

Addressing Risks Derived From the Commodification of Substances of Human Origin: A European Proposal Applicable Worldwide

Commodification; Human substancesMercantilització; Substàncies humanesMercantilización; Sustancias humanasIn view of the public consultation recently launched by the World Health Organization on Regulatory Convergence of Cell and Gene Therapy Products and the Proposal for a Regulation on substances of human origin (SoHO) repealing the European Union Directives on Blood and on Tissues and Cells, an opportunity arises to define an ethical and transparent framework of collaboration between industry and authorities responsible for SoHO-derived products, comprising medicines, medical devices, transfusion, and transplantation. The commodification of SoHO-derived medicinal products and medical devices entails important risks to the sustainability of healthcare systems and threatens the equitable access of patients to innovative therapies. It may also jeopardize the principle of altruistic donation of SoHO that is required for the treatment and survival of thousands of patients every year. This article puts forward several proposals aimed at reconciling the ethical principles of voluntary and unpaid SoHO donation and the noncommercialization of the human body with obtaining a profit that allows business activities, while ensuring high quality, safety, and efficacy standards of tissues and cells for clinical use

Drug regulation in Bulgaria

Цел: Целта на настоящата статия е да проследи ролята на лекарствената регулация в България и дейността на Изпълнителната агенция по лекарства във фармацевтичния сектор.Лекарствена регулация е съвременният международно приет термин за обозначаване на съвкупността от активности, които държавата упражнява в различни сфери на фармацевтичния сектор, за да осигури обществото с качествени, ефикасни и безопасни лекарства. Контролът върху дейността с лекарствени форми в България се осъществява от Изпълнителна агенция по лекарствата (ИАЛ), създадена към Министерство на здравеопазването. Основни форми за контрол на дейностите, извършвани в търговията на складовете, аптеките и дрогериите, са проверка, инспекция и обследване. Те могат да се извършват само от длъжностни лица - инспектори от съответните компетентни органи, имащи право на контрол след задължително легитимиране. Когато са допуснати сериозни слабости и нарушения на нормативните документи, се съставя акт за установяване на административно нарушение, който може да е последван от наказателно постановление, съдържащо предвидените в закона наказания - финансови, административни, наказателни, професионални. Цялостната дейност на агенцията по изпълнение на целите на законите включва и дейности по изпълнение на цели от Национална здравна стратегия на Министерството на здравеопазването и участие в дейностите, свързани с работата на Европейската агенция по лекарствата, Европейския директорат по качеството на лекарствата и здравеопазване, на международни органи и организации, както и с изпълнението на международни договори, по които Република България е страна. Всички те работят в името на една и съща цел - да опазват здравето на обществото чрез осигуряването му с лекарства, които покриват международни стандарти за качество, ефикасност и безопасност.Методи и материали: Направен е преглед на нормативни документи относно дейността на Изпълнителната агенция по лекарства според сега действащото законодателство. Проведена е анонимна анкета сред работещи фармацевти в аптеките на територията на град Варна относно дейността на ИАЛ и нейните контролни функции. Сравнена е дейността на ИАЛ и ЕМА.Резултати: Резултатите от анкетата, проведена сред фармацевти на територията на град Варна, отчитат необходимостта от прецизиране на нормативните наредби и засилване на контрола по отношение на изпълнението им. ИАЛ синхронизира дейността си съгласно европейското законодателство и българската нормативна уредба.Aim: The aim of this article is to track the role of drug regulation in Bulgaria and the activities of the Bulgarian Drug Agency (BDA) in the pharmaceutical sector.Drug regulation is the internationally accepted term for the aggregation of activities which the state exercises in various areas of the pharmaceutical sector in order to provide the public with quality, effective and safe medicines. The control in drug regulation and legislation in Bulgaria is performed by the Bulgarian Drug Agency (BDA), established at the Ministry of Health. Main forms of control the activities carried out in retail stores, pharmacies and drugstores are regular checks, inspections and investigations. They can only be carried out by inspectors from the competent authorities authorized to control after the required legitimacy. When serious violations of regulations are established, a penalty act is issued to confirm administrative offense, which may be followed by a penal provision containing the penalties provided by law - financial, administrative, criminal, and professional. The overall activity of the Agency in implementing the objectives of the law includes activities in implementing the goals of the National Health Strategy of the Ministry of Health and participation in activities related to the work of the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines and Health, international agencies and organizations, as well as the implementation of international treaties to which Bulgaria is a party. They all act with the same goal - to protect public health by providing it with drugs that meet international standards for quality, efficiency and safety.Materials and Methods: A review of regulatory documents on the activities of the Bulgarian Drug Agency under current law was done. We have conducted an anonymous survey among pharmacists working in Varna. It focused on the activities of the BDA and its control functions. The activities of BDA and EMA were compared.Results: The results of the survey conducted among pharmacists working in Varna reports the need for more precise legal regulations and strengthening the control over their implementation. BDA synchronizes its activity in accordance with both the European legislation and the Bulgarian one

Optimizirano određivanje lorazepama u humanom serumu visokotlačnom tekućinskom kromatografijom

The present research was designated to evaluate a rapid and sensitive method for determining low concentrations of the highly active drug lorazepam in serum. Isolation of the drug from biological fluid after addition of nordazepam as the internal standard was achieved using a simple liquid-liquid extraction with dichloromethane and the extracted compounds were quantified by high-performance liquid chromatography. Chromatographic separation on a reversed phase column containing a stationary phase with low silanol activity resulted in a perfectly symmetrical peak with a tailing factor of 1.0. The limit of quantitation in serum is 2.5 ng mL-1 for both lorazepam and internal standard. The procedure is rapid and sensitive enough for determination of lorazepam in serum.U radu se vrednuje brza i osjetljiva metoda za određivanje niskih koncentracija lorazepama u serumu. Lorazepam je izoliran iz seruma ekstrakcijom diklormetanom, zajedno s nordazepamom, koji je upotrebljen kao interni standard i zatim određivan visokotlačnom tekućinskom kromatografijom. Kromatografskim razdjeljivanjem na reverzno-faznoj koloni sa stacionarnom fazom s niskom aktivnošću silanola dobiveni su potpuno simetrični signali faktorom završnog povlačenja 1,0. Granica određivanja u serumu je 2,5 ng mL-1 za lorazepam i interni standard. Metoda je brza i dovoljno osjetljiva za određivanje lorazepama u serumu

Optimizirano određivanje lorazepama u humanom serumu visokotlačnom tekućinskom kromatografijom

The present research was designated to evaluate a rapid and sensitive method for determining low concentrations of the highly active drug lorazepam in serum. Isolation of the drug from biological fluid after addition of nordazepam as the internal standard was achieved using a simple liquid-liquid extraction with dichloromethane and the extracted compounds were quantified by high-performance liquid chromatography. Chromatographic separation on a reversed phase column containing a stationary phase with low silanol activity resulted in a perfectly symmetrical peak with a tailing factor of 1.0. The limit of quantitation in serum is 2.5 ng mL-1 for both lorazepam and internal standard. The procedure is rapid and sensitive enough for determination of lorazepam in serum.U radu se vrednuje brza i osjetljiva metoda za određivanje niskih koncentracija lorazepama u serumu. Lorazepam je izoliran iz seruma ekstrakcijom diklormetanom, zajedno s nordazepamom, koji je upotrebljen kao interni standard i zatim određivan visokotlačnom tekućinskom kromatografijom. Kromatografskim razdjeljivanjem na reverzno-faznoj koloni sa stacionarnom fazom s niskom aktivnošću silanola dobiveni su potpuno simetrični signali faktorom završnog povlačenja 1,0. Granica određivanja u serumu je 2,5 ng mL-1 za lorazepam i interni standard. Metoda je brza i dovoljno osjetljiva za određivanje lorazepama u serumu

Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana

Purpose: The study was carried out to evaluate the quality of artesunate tablets sold in retail and wholesale pharmacies in Kumasi, Ghana. In particular, the study sought to ascertain the presence or otherwise of counterfeit artesunate tablets in Kumasi. Method: Artesunate tablets were purchased from pharmacies in Kumasi for the study. The mechanical properties of the tablets were evaluated, namely: uniformity of weight, breaking strength, friability and rate of disintegration in aqueous medium. Colorimetric methods were used to determine the presence of artesunate and to assay the tablets. Result: None of the artesunate tablets sampled was found to be a counterfeit. Most of the brands had acceptable mechanical properties in terms of mass uniformity, hardness, friability and disintegration time. However, the artesunate content of the tablets was variable (47.9-99.9 %). Six (35.3 %) of the samples passed the International Pharmacopoeia content uniformity test (93.7-99.9 %) while 11 (64.7 %) failed the test (47.9-89.4 %). However, only 3 (17.6 %) of the samples met the European Pharmacopoeia (Ph. Eur.) content requirements while 14 (82.4 %) failed to meet the requirements. Conclusion: The presence of substandard artesunate tablets on the Ghanaian market should alert drug regulatory authorities to be vigilant and continually monitor the quality of this life-saving drug. Keywords: Artesunate tablets, Artemisinins, Fast-red TR salt, Counterfeit drugs, Substandard drugs.Tropical Journal of Pharmaceutical Research Vol. 7(4) 2008: pp. 1179-118

The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines.

To access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked FilesFalsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.The tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value.In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.This "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts.EDQ

IMPLICATIONS OF MOBILE PHASE COMPOSITION AND PH ON THE CHROMATOGRAPHIC SEPARATION OF AMITRIPTYLINE AND ITS METABOLITE NORTRIPTYLINE

Objective: Separation of tricyclic compounds sets the keystone for determining parent drug to metabolite concentration ratios and analysing impurities. The combined effects of acetonitrile composition and pH of the mobile phase on the separation of amitriptyline and nortriptyline by reversed-phase high-performance liquid chromatography (RP-HPLC) are presented.Methods: A series of RP-HPLC triplicate runs were carried out using acetonitrile and a phosphate buffer as the mobile phase and a Kinetex® C18 LC Column as the stationary phase using an Agilent 1260 Infinity Series® II liquid chromatography system with UV/visible detection. The stationary phase, column temperature, injection volume and flow rate were kept unchanged during analysis. Mobile phase composition and pH were varied to observe impact on peak shape, resolution and retention time, taking into consideration green analytical chemistry aspects.Results: Optimal chromatographic outcomes were achieved when using the mobile phase made up of 35% acetonitrile and 65% buffer at a pH of 5.6. These conditions resulted in nortriptyline and amitriptyline eluting at 4.66 min and 5.92 min respectively. Increasing the organic modifier content of the mobile phase to 40% completed separation within a run time of 4 min with comparable resolution. The 2 min gained by increasing 5% acetonitrile may not be justified due to potential implications on greening laboratory practices.Conclusion: Reversed-phase chromatography embodies a simple method for the separation of compounds that are similar in structure. Attuning the percentage of organic modifier and buffer pH provides acceptable retention times, without compromising resolution between neighbouring peaks