scholarly journals Evaluation of the Quality of Artemisinin-Based Antimalarial Medicines Distributed in Ghana and Togo

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Dorcas Osei-Safo ◽  
Amegnona Agbonon ◽  
Daniel Yeboah Konadu ◽  
Jerry Joe Ebow Kingsley Harrison ◽  
Mamadou Edoh ◽  
...  
Keyword(s):  
Failure Rate ◽  
Quality Evaluation ◽  
Active Pharmaceutical Ingredients ◽  
Hplc Assay ◽  
Pharmaceutical Ingredients ◽  
Cross Border ◽  
Border Towns ◽  
Medicine Quality ◽  
Accurate Quantification

This study, conducted as part of our overall goal of regular pharmacovigilance of antimalarial medicines, reports on the quality of 132 artemisinin-based antimalarial medicines distributed in Ghana and Togo. Three methods were employed in the quality evaluation—basic (colorimetric) tests for establishing the identity of the requisite active pharmaceutical ingredients (APIs), semi-quantitative TLC assay for the identification and estimation of API content, and HPLC assay for a more accurate quantification of API content. From the basic tests, only one sample totally lacked API. The HPLC assay, however, showed that 83.7% of the ACTs and 57.9% of the artemisinin-based monotherapies failed to comply with international pharmacopoeia requirements due to insufficient API content. In most of the ACTs, the artemisinin component was usually the insufficient API. Generally, there was a good correlation between the HPLC and SQ-TLC assays. The overall failure rates for both locally manufactured (77.3%) and imported medicines (77.5%) were comparable. Similarly the unregistered medicines recorded a slightly higher overall failure rate (84.7%) than registered medicines (70.8%). Only two instances of possible cross-border exchange of medicines were observed and there was little difference between the medicine quality of collections from border towns and those from inland parts of both countries.

scholarly journals Quality Assessment of Antibiotic Oral Drug Formulations Marketed In Katsina State, Nigeria

1970 ◽  
Vol 7 (6) ◽  
pp. 6-10
Author(s):  
Mukhtar Gambo Lawal ◽  
Muhammad Dauda Mukhtar ◽  
Abdulkadir Magaji Magashi
Keyword(s):  
Active Ingredient ◽  
Active Pharmaceutical Ingredient ◽  
Oral Drug ◽  
Active Pharmaceutical Ingredients ◽  
Hplc Assay ◽  
Drug Formulations ◽  
Percentage Content ◽  
Pharmaceutical Ingredients ◽  
Three Samples ◽  
High Incidence

There are increasing reports on the high incidence of substandard drugs, especially in developing countries.Pharmaceutical products have been reported to contain either no, low, or excessive amounts of the active pharmaceutical ingredient (API). Inview of the above, 112 samples of six different antibiotic oral drug formulations were evaluated for chemical quality by assessing the presence and the percentage content of the stated active pharmaceutical ingredients using validated HPLC assay as described in the official monograph of the British and United Stated pharmacopoeia. The result indicates that 43 (38.4%) had active ingredients outside the set pharmacopoeial limit and therefore were non-compliant to the BP and the USP specifications for percentage content.  Ampiclox and Cotrimoxazole had the highest proportion of samples with active ingredient outside the pharmacopoeial limit, and in three samples (one Augmentin and two Ampiclox), no active ingredient was detected. The presence of API lower than the claimed content declared on the packaging was the primary cause of non-compliance. The potential implications of the use of substandard drugs are treatment failure and the development of drug-resistance.  

scholarly journals Determination of the glucose residues on pharmaceutical equipment surfaces by both methods: polarimetry and HPLC

2018 ◽  
pp. 83-89
Author(s):  
A. А. Fedosenko ◽  
Yu. V. Scrypynets ◽  
I. I. Leonenko ◽  
A. V. Yegorova ◽  
S. N. Kashutskуy ◽  
...  
Keyword(s):  
Good Manufacturing Practice ◽  
Oral Solution ◽  
Process Equipment ◽  
Cross Contamination ◽  
Active Pharmaceutical Ingredients ◽  
Rapid Methods ◽  
Membrane Filters ◽  
Pharmaceutical Ingredients

Cleaning of equipment in the production of medicines is an important requirement of good manufacturing practice (GMP). As a rule, the same process equipment is used for the production of a number of different drugs that may result in cross-contamination. In order to prevent the contamination there is need in efficient cleaning of equipment used with the validation methods for each part of equipment. There is need as well to prove and establish acceptable residual limits of active pharmaceutical ingredients (API) on the surface of the equipment after purification (purity acceptance criteria) based on the therapeutic dose of API, toxicity, volume of series, the surface area of the used equipment. The aim of this work is the development of the simple and selective polarimetry and HPLC methods for determining residual amounts of glucose in washings from surfaces of pharmaceutical equipment after production of the drug. The object of the research is glucose, which is a part of the drug Regidron, powder for oral solution of 18.9 g per sachet. The swab Alpha® Sampling Swab TX715; membrane filters 0.20 µm; Minisart RC 15 «Sartorius» (Germany) were used. The polarimetric and HPLC methods for determination of glucose residues in washings from surfaces of pharmaceutical equipment after production the Regidron were developed. The recovery rates of glucose from swabs and pharmaceutical equipment surfaces are more than 90%. The proposed simple and rapid methods are characterized by satisfactory metrological characteristics and can be recommended to determine the residues of glucose in controlling the quality of cleaning pharmaceutical equipment.

scholarly journals Further Validation of a Rapid Screening Semiquantitative Thin-Layer Chromatographic Method for Marketed Antimalarial Medicines for Adoption in Malawi

2018 ◽  
Vol 2018 ◽  
pp. 1-7
Author(s):  
Dorcas Osei-Safo ◽  
Ibrahim Chikowe ◽  
Jerry Joe Ebow Kingsley Harrison ◽  
Daniel Konadu Yeboah ◽  
Ivan Addae-Mensah
Keyword(s):  
Thin Layer ◽  
Screening Tool ◽  
Retention Factor ◽  
Essential Medicines ◽  
Rapid Screening ◽  
Hplc Assay ◽  
Pharmaceutical Ingredients ◽  
Accuracy And Precision ◽  
Field Estimation

A recently developed semiquantitative thin-layer chromatographic (SQ-TLC) assay has been employed in postmarketing surveillance of antimalarial medicines used in Malawi prior to HPLC assay. Both methods gave analogous results in a significant majority of the samples, with a good correlation (r = 0.9012) for the active pharmaceutical ingredients of the dosage forms assayed. Artemether-containing medicines had the highest percentage (92.67%) of samples with comparable results for both assays. The lowest percentage (66.67%) was observed in artesunate-containing medicines. The SQ-TLC method was validated for specificity, accuracy, precision, linearity, and stability according to the International Conference on Harmonisation guidelines, with the results falling within acceptable limits. For specificity, retention factor values of the test samples and reference standards were comparable, while accuracy and precision of 91.1 ± 5.7% were obtained for all samples. The method was linear in the range 1.0–2.0 µg/spot with a correlation coefficient ofr = 0.9783. Stability tests also fell within acceptable limits. In this study, we present the validation of the SQ-TLC method and propose its adoption as a rapid screening tool for field estimation of the quality of antimalarial and other essential medicines in Malawi and other parts of the developing world prior to a more accurate HPLC assay.

scholarly journals Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients

2018 ◽  
Vol 6 (3) ◽  
pp. 69-74
Author(s):  
Priyanka D Debaje ◽  
Gurmeet S. Chhabra ◽  
Nayan Gujarathi
Keyword(s):  
Raw Materials ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Cleaning Validation ◽  
Cleaning Agents ◽  
Predetermined Level ◽  
Extraneous Material

 Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust,  lubricants, raw materials,  intermediates, etc. In the manufacturing of the pharmaceutical products, it is a must to reproduce consistently the desired quality of product. Residual material from the previous batch of the same product or from different product may be carried to the next batch of the product, which in turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning method employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level The purpose of this review is to provide information about importance of cleaning validation of API in pharmaceutical industry and this information is in accordance with the regulatory guidelines

scholarly journals Research progress on quality assurance of genuine Chinese medicinal in Sichuan

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hua Luo ◽  
Yi Zhao ◽  
Hua Hua ◽  
Yan Zhang ◽  
Xiaobo Zhang ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Chinese Medicine ◽  
Quality Evaluation ◽  
Technology Development ◽  
Wide Distribution ◽  
Research Progress ◽  
High Quality ◽  
Ecological Protection ◽  
Medicine Quality

AbstractThe genuine Chinese medicinal (GCM), also known as Dao-di Herbs, is a synonym for high quality Chinese medicinal materials, which has been established in thousands of years of clinical practice and is a comprehensive standard for evaluating the quality of Chinese medicinal materials. The newest data from the Fourth National Survey of Chinese Medicinal Resources showed that Sichuan Province has 7290 types of Chinese medicine and 86 GCM, both ranking highly in China. The characteristics like diverse species, wide distribution, higher yield, and good quality are considered as advantages of geo-herbals grown in Sichuan. Resources guarantee and high-quality development of those medicine materials make a difference in local Chinese medicine quality promotion and Chinese medicine industry and technology development to serve the public's needs, assist targeted poverty alleviation, and strengthen ecological protection. This review aims to outline significant progress in the recent ten years regarding regionalization, germplasm resources, and quality evaluation around the quality assurance of GCM in Sichuan, China.

scholarly journals Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

2018 ◽  
Vol 24 (21) ◽  
pp. 2456-2472 ◽  
Author(s):  
Chandrakant R. Malwade ◽  
Haiyan Qu
Keyword(s):  
Pharmaceutical Industry ◽  
Process Analytical Technology ◽  
Polymorphic Form ◽  
Active Pharmaceutical Ingredients ◽  
Drug Products ◽  
Pharmaceutical Ingredients ◽  
Particle Size And Shape ◽  
And Control

Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities. Crystallization with its ability to engineer the final product to the desired qualities such as purity, polymorphic form, particle size and shape is one of the most important steps involved in the manufacturing of APIs. Therefore, development of crystallization processes with better understanding of process parameters and their impact on quality of APIs and subsequently the drug products assume great significance for the pharmaceutical industry. Methods: This review paper focuses on the application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design of crystallization processes in the manufacturing of APIs. Results: Firstly, various steps involved in the drug development process are introduced briefly with emphasis on crystallization as one of the most important steps in manufacturing of drug products. Secondly, Critical Quality Attributes (CQAs) of drug products, their dependence on material attributes of APIs and role of crystallization in manipulating material attributes of APIs has been discussed. Finally, application of PAT tools such as advanced process analyzers for continuous monitoring, chemometric methods for multivariate data analysis, and control strategy for APIs crystallization processes has been reviewed along with some examples. Conclusion: Application of PAT in crystallization of APIs facilitates development of robust processes that works within the design space to produce the drug products of consistent quality. Furthermore, it opens up the opportunities for continuous improvement of the process by generating knowledge base of existing processes.

scholarly journals Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

2021 ◽  
Author(s):  
Cathrin Hauk ◽  
Nhomsai Hagen ◽  
Lutz Heide
Keyword(s):  
Chemical Analysis ◽  
Active Pharmaceutical Ingredients ◽  
Total Rate ◽  
Tolerance Limits ◽  
Dr Congo ◽  
Middle Income ◽  
Pharmaceutical Ingredients ◽  
Middle Income Countries ◽  
Falsified Medicines ◽  
Medicine Quality

Substandard and falsified medicines have severe public health and socioeconomic effects, especially in low- and middle-income countries. The WHO has emphasized the need for reliable estimates of the prevalence of such medicines to efficiently respond to this problem. In the present study, we used 601 medicine samples collected in Cameroon, the DR Congo, and Malawi to assess the rates of substandard and falsified medicines based on different criteria. Based on the specifications of the U.S. Pharmacopoeia for the amount of the active pharmaceutical ingredients, the rate of out-of-specification medicines was 9.3%. By contrast, this rate ranged from 3.3% up to 35.0% if the tolerance limits of other pharmacopoeias or recently published medicine quality studies were used. This shows an urgent need for harmonization. Principal methods to assess the rate of falsified medicines are packaging analysis, chemical analysis, and authenticity inquiries. In the present study, we carried out an authenticity inquiry for the aforementioned medicine samples, contacting 126 manufacturers and 42 distributors. Response rates were higher for samples stated to be manufactured in Asia (52.4%) or Europe (53.8%) than for samples manufactured in Africa (27.4%; P < 0.001). One sample had been identified as falsified by packaging analysis by the local researchers and two additional ones by chemical analysis. Notably, seven additional falsified samples were identified by the authenticity inquiries. The total rate of falsified medicines resulted as 1.7%. Considerations are discussed for assessing the rates of “substandard” and “falsified” medicines in future medicine quality studies.

A REVIEW ON HERBAL EXCIPIENTS

2021 ◽  
pp. 05-08
Author(s):  
Arpita singh ◽  
Nidhi Gupta ◽  
Amresh Gupta
Keyword(s):  
Dosage Form ◽  
Low Cost ◽  
Dosage Forms ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Gum Acacia ◽  
Different Types ◽  
Great Merit ◽  
Novel Drug

The Herbal or natural excipients have great merit over their synthetic analogs as these are non-toxic, low-cost, and freely obtainable. The performance of the excipients partly determines the quality of the medicines. The plant acquired gums, mucilage from the natural origin for example carrageenan, thaumatin, lard, storax, agar, gum acacia, tragacanth, and excipients.  They can also be easily altered to meet the specific needs, thereby being a potent many more to name comply with many requirements of the pharmaceutical and economic vehicle for transporting active pharmaceutical ingredients in the formulation. Thus present study aims to throw light on the probable of natural excipients which can be present to be used as a diluent, binder, disintegrant as well as lubricant in different types of formulations as they are biocompatible and capable of giving additional nutrition to the developed dosage form. This article gives an overview of natural excipients which are used in conventional dosage forms as well as novel drug delivery systems.

X-ray diffraction characterization of different polymorphyc forms of clopidogrel bisulphate in substance and pharmaceutical dosage form

2013 ◽  
Vol 37 (1) ◽  
pp. 55-60
Author(s):  
Olivera R. Klisurića ◽  
Srđan J. Rakića ◽  
Miroslav J. Cvetinov ◽  
Maja M. Stojanović ◽  
Andrea R. Nikolić ◽  
...  
Keyword(s):  
Room Temperature ◽  
Active Pharmaceutical Ingredients ◽  
Stability Studies ◽  
X Ray Diffraction ◽  
Melting Points ◽  
Pharmaceutical Dosage Form ◽  
X Ray ◽  
Pharmaceutical Ingredients

Abstract The present study deals with the application of X-ray powder diffraction (XRPD) analysis as a technique for identification of the forms of clopidogrel bisulphate (CLP) present in both the active pharmaceutical ingredients (API) and tablets, specifically addressing the question of whether API converts to another form after 12 months of storage. The investigation of the possibility of phase transitions occurring over a temperature range spanning from room temperature to the melting point, both in tablets and pure CLP, were also performed. Tablet samples were observed for the changes in their structure using polarizing optical microscopy, which was also used to determine the melting points of tablet samples. The results gained during this work confirm that XRPD is applicable for API and tablets testing. This is particularly important if we take into account that the method can be used during stability studies, i.e. in order to test the quality of tablets during the validity period.

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