Objective: A simple, precise and accurate reversed phase high-performance liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the simultaneous estimation of Nebivolol HCl and Cilnidipine in tablet formulation. Methods: The adequate separation was carried out using Grace Smart C18 column (250 mm x 4.6 mm, 5 μm particle size), mixture of 0.05 M Potassium dihydrogen phosphate PH 5.0 and Methanol 30:70 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 225 nm using PDA detector. The retention time of Nebivolol HCl and Cilnidipine were 4.057 min and 6.470 min respectively. Results: Linearity for Nebivolol HCl and Cilnidipine were found in the range of 5-15 µg/ml and 10-30 µg/ml (R 2 = 0.998) respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The % recoveries of both drugs were found to be in range of 99.698-100.108% and 99.497-99.512% for Nebivolol HCl and Cilnidipine respectively. Precision studies were carried out and the RSD values were less than two. The method was found to be robust. Conclusions: The proposed method was found to be specific, accurate, precise and robust can be used for simultaneous estimation of these drugs in tablet dosage form.
{"title":"Development and validation of reversed phase high performance liquid chromatography method for simultaneous estimation of Nebivolol HCl and Cilnidipine in combined tablet dosage form","authors":"B. Patel, Ankit Chaudhary, P. Parmar, Vidhi Patel","doi":"10.5281/ZENODO.51063","DOIUrl":"https://doi.org/10.5281/ZENODO.51063","url":null,"abstract":"Objective: A simple, precise and accurate reversed phase high-performance liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the simultaneous estimation of Nebivolol HCl and Cilnidipine in tablet formulation. Methods: The adequate separation was carried out using Grace Smart C18 column (250 mm x 4.6 mm, 5 μm particle size), mixture of 0.05 M Potassium dihydrogen phosphate PH 5.0 and Methanol 30:70 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 225 nm using PDA detector. The retention time of Nebivolol HCl and Cilnidipine were 4.057 min and 6.470 min respectively. Results: Linearity for Nebivolol HCl and Cilnidipine were found in the range of 5-15 µg/ml and 10-30 µg/ml (R 2 = 0.998) respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The % recoveries of both drugs were found to be in range of 99.698-100.108% and 99.497-99.512% for Nebivolol HCl and Cilnidipine respectively. Precision studies were carried out and the RSD values were less than two. The method was found to be robust. Conclusions: The proposed method was found to be specific, accurate, precise and robust can be used for simultaneous estimation of these drugs in tablet dosage form.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75155725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Buccal delivery involves the administration of the desired drug through the buccal mucosal membrane lining of the oral cavity. The objective of this article is to review buccal drug delivery by discussing the structure and environment of the oral mucosa and highlighting the mechanisms of drug permeation and methodology in evaluating buccal formulations. This review also highlights a brief description of advantages, limitations of buccal drug delivery and theories involved in mucoadhesion along with method of preparation mucoadhesive system, mucoadhesive polymer, and classification of buccal system.
{"title":"CURRENT APPROACHES IN BUCCAL DRUG DELIVERY SYSTEM","authors":"Shrutika M. Gawas, A. Dev, G. Deshmukh, S. Rathod","doi":"10.5281/ZENODO.51059","DOIUrl":"https://doi.org/10.5281/ZENODO.51059","url":null,"abstract":"Buccal delivery involves the administration of the desired drug through the buccal mucosal membrane lining of the oral cavity. The objective of this article is to review buccal drug delivery by discussing the structure and environment of the oral mucosa and highlighting the mechanisms of drug permeation and methodology in evaluating buccal formulations. This review also highlights a brief description of advantages, limitations of buccal drug delivery and theories involved in mucoadhesion along with method of preparation mucoadhesive system, mucoadhesive polymer, and classification of buccal system.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74671190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Krishna V. Prajapati, H. Raj, V. Jain, Neelam S. Prajapati
Objective: The present study was aimed to describe a simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of Mesalazine (MESA) and Rifaximin (RIFA) in synthetic mixture. Methods: The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in 0.01 N NaOH and the determinations were made at 329.20 nm (ZCP of RIFA) for MESA and 292.80 nm (ZCP of MESA) for RIFA. The linearity was obtained in the concentration range of succinate 10-50 μg/ml for MESA and 10-50 μg/ml for RIFA. Results: The limit of determination was 0.321 μg/ml and 0.301 μg/ml for MESA and RIFA, respectively. The limit of quantification was 0.974 μg/ml and 0.912 μg/ml for MESA and RIFA, respectively. The mean recovery was 100.20 and 99.52% for MESA and RIFA, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of MESA and RIFA in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which is considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So, this method accurate, precise, robust, rugged and economic in nature.
{"title":"First derivative spectroscopic method for simultaneous estimation of mesalazine and rifaximin in synthetic mixture","authors":"Krishna V. Prajapati, H. Raj, V. Jain, Neelam S. Prajapati","doi":"10.5281/ZENODO.51068","DOIUrl":"https://doi.org/10.5281/ZENODO.51068","url":null,"abstract":"Objective: The present study was aimed to describe a simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of Mesalazine (MESA) and Rifaximin (RIFA) in synthetic mixture. Methods: The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in 0.01 N NaOH and the determinations were made at 329.20 nm (ZCP of RIFA) for MESA and 292.80 nm (ZCP of MESA) for RIFA. The linearity was obtained in the concentration range of succinate 10-50 μg/ml for MESA and 10-50 μg/ml for RIFA. Results: The limit of determination was 0.321 μg/ml and 0.301 μg/ml for MESA and RIFA, respectively. The limit of quantification was 0.974 μg/ml and 0.912 μg/ml for MESA and RIFA, respectively. The mean recovery was 100.20 and 99.52% for MESA and RIFA, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of MESA and RIFA in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which is considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So, this method accurate, precise, robust, rugged and economic in nature.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73028725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: A simple, specific, and fast stability indicating reverse phase liquid chromatographic method was established for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations. The High Performance Liquid Chromatography method has adequate separation of Ofloxacin and Prednisolone in its dosage form. Methods: The separation was achieved by BDS Hypersil C 18 , with mobile phase Phosphate Buffer (potassium dihydrogen posphate) (pH 4): Methanol (30:70 v/v).The mobile phase at a flow rate of 1.0 ml/min. Injection volume 20 μl and wavelength of detection used was 275 nm. The retention time for Ofloxacin and Prdnisolone were obtained as 3.327 min and 5.680 min, respectively. Results: The linearity of proposed method was investigated in range of 3-9 μg/ml and 10-30 μg/ml for Ofloxacin and Prednisolone respectively. The precision data for Ofloxacin and Prednisolone were found to be 0.42% and 0.90% respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The Accuracy data for Ofloxacin and Prednisolone were found to be 1.12-0.49% RSD and 0.67-0.53% RSD respectively. LOD value was found to be 0.014 for Ofloxacin and 0.0297 for Prednisolone. LOQ value was found to be 0.042 for Ofloxacin and 0.090 for Prednisolone. Conclusions: The method was found to be accurate, precise, specific, sensitive and robust according to acceptance criteria of International Council on Harmonization (ICH) guidelines. The method was resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution. The peak purity index for both the analytes after all types of stress conditions was ≥0.9999 indicated a complete separation of both the analyte peaks from degradation products. The developed method can be applied successfully for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations and their stability studies.
{"title":"Development and validation of stability indicating method for simultaneous estimation of ofloxacin and prednisolone in pharmaceutical dosage form","authors":"T. Solanki, Subhashchandra K. Patel, B. Patel","doi":"10.5281/ZENODO.51074","DOIUrl":"https://doi.org/10.5281/ZENODO.51074","url":null,"abstract":"Objective: A simple, specific, and fast stability indicating reverse phase liquid chromatographic method was established for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations. The High Performance Liquid Chromatography method has adequate separation of Ofloxacin and Prednisolone in its dosage form. Methods: The separation was achieved by BDS Hypersil C 18 , with mobile phase Phosphate Buffer (potassium dihydrogen posphate) (pH 4): Methanol (30:70 v/v).The mobile phase at a flow rate of 1.0 ml/min. Injection volume 20 μl and wavelength of detection used was 275 nm. The retention time for Ofloxacin and Prdnisolone were obtained as 3.327 min and 5.680 min, respectively. Results: The linearity of proposed method was investigated in range of 3-9 μg/ml and 10-30 μg/ml for Ofloxacin and Prednisolone respectively. The precision data for Ofloxacin and Prednisolone were found to be 0.42% and 0.90% respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The Accuracy data for Ofloxacin and Prednisolone were found to be 1.12-0.49% RSD and 0.67-0.53% RSD respectively. LOD value was found to be 0.014 for Ofloxacin and 0.0297 for Prednisolone. LOQ value was found to be 0.042 for Ofloxacin and 0.090 for Prednisolone. Conclusions: The method was found to be accurate, precise, specific, sensitive and robust according to acceptance criteria of International Council on Harmonization (ICH) guidelines. The method was resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution. The peak purity index for both the analytes after all types of stress conditions was ≥0.9999 indicated a complete separation of both the analyte peaks from degradation products. The developed method can be applied successfully for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations and their stability studies.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84859566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: It describes Simultaneous estimation of simple, accurate, precise, robust and economical Q-Absorbance ratio spectrophotometric method for Atenolol and Ivabradine HCl in synthetic mixture. Objective of the study was to deliver information related to Ivabradine HCl and Atenolol combination’s analytical method. Methods: Absorbance ratio method for the ratio of absorbance at two selected wavelengths, one which is an iso-absorbtive point and other being the λ-max of one of the two components. Atenolol and Ivabradine HCl showed an iso-absorbtive point at 286.40 nm in methanol. The second wavelength used was 276 nm which is λ max of Atenolol in methanol. So it was economic in nature. The linearity was obtained in the concentration range of 20-100 µg/ml for Atenolol and 2-10 µg/ml for Ivabradine HCl. The concentration of the drugs was determined by using ratio of absorbance at iso-absorbtive point and at the λ max of Atenolol. Results: This method is linear for both drugs; in range 2-10 µg/ml for Ivabradine HCl and 20-100 µg/ml for Atenolol found at λ max of Atenolol 276nm (R 2 = 0.9990) and at Iso-absorptive point 286.40 nm (R 2 = 0.9998). % recovery for Ivabradine HCl found 100.47% and Atenolol 100.32%. And all validation parameter (Robustness, Ruggedness, Interday, Intraday) show %RSD >2%. And Limit of detection for Ivabradine HCl and Atenolol at λ 1 (maximum wavelength) and λ 2 (Iso-absorptive point) was found 0.309 and 0.181 respectively. % Assay for Ivabradine HCl and Atenolol found to be 100.58% and 100.13% respectively. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which was considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.
{"title":"Q-absorbance ratio spectrophotometric method for simultaneous determination of atenolol and ivabradine hydrochloride in synthetic mixture","authors":"P. Patil, H. Raj, Gautam B. Sonara","doi":"10.5281/ZENODO.51066","DOIUrl":"https://doi.org/10.5281/ZENODO.51066","url":null,"abstract":"Objective: It describes Simultaneous estimation of simple, accurate, precise, robust and economical Q-Absorbance ratio spectrophotometric method for Atenolol and Ivabradine HCl in synthetic mixture. Objective of the study was to deliver information related to Ivabradine HCl and Atenolol combination’s analytical method. Methods: Absorbance ratio method for the ratio of absorbance at two selected wavelengths, one which is an iso-absorbtive point and other being the λ-max of one of the two components. Atenolol and Ivabradine HCl showed an iso-absorbtive point at 286.40 nm in methanol. The second wavelength used was 276 nm which is λ max of Atenolol in methanol. So it was economic in nature. The linearity was obtained in the concentration range of 20-100 µg/ml for Atenolol and 2-10 µg/ml for Ivabradine HCl. The concentration of the drugs was determined by using ratio of absorbance at iso-absorbtive point and at the λ max of Atenolol. Results: This method is linear for both drugs; in range 2-10 µg/ml for Ivabradine HCl and 20-100 µg/ml for Atenolol found at λ max of Atenolol 276nm (R 2 = 0.9990) and at Iso-absorptive point 286.40 nm (R 2 = 0.9998). % recovery for Ivabradine HCl found 100.47% and Atenolol 100.32%. And all validation parameter (Robustness, Ruggedness, Interday, Intraday) show %RSD >2%. And Limit of detection for Ivabradine HCl and Atenolol at λ 1 (maximum wavelength) and λ 2 (Iso-absorptive point) was found 0.309 and 0.181 respectively. % Assay for Ivabradine HCl and Atenolol found to be 100.58% and 100.13% respectively. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which was considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76847572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Krishna V. Prajapati, H. Raj, V. Jain, Neelam S. Prajapati
Objective: A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Mesalazine and Rifaximin in synthetic mixture using Simultaneous Equation Method. Objective of the study was to deliver information related to Mesalazine and Rifaximin combination’s analytical method. Methods: The absorbance was measured at 328 nm for Mesalazine and 292 nm for Rifaximin and calibration curves were plotted as absorbance versus concentration, respectively. The method was found to be linear (r 2 > 0.999) in the range of 10-50 μg/ml for Mesalazine at 328 nm. The linear correlation was obtained (r 2 > 0.999) in the range of 10-50 μg/ml for Rifaximin at 292 nm. Results: The limit of determination (LOD) was 0.215 μg/ml and 0.214μg/ml for Mesalazine and Rifaximin respectively. The limit of quantification (LOQ) was 0.652 μg/ml and 0.648 μg/ml for Mesalazine and Rifaximin respectively. The accuracy of this method was evaluated by recovery studies and good recovery results were obtained greater than 99%. The method was successfully applied for simultaneous determination of Mesalazine and Rifaximin in binary mixture. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which is considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.
{"title":"SIMULTANEOUS DETERMINATION OF MESALAZINE AND RIFAXIMIN IN SYNTHETIC MIXTURE USING SPECTROPHOTOMETRIC TECHNIQUE (SIMULTANEOUS EQUATION METHOD)","authors":"Krishna V. Prajapati, H. Raj, V. Jain, Neelam S. Prajapati","doi":"10.5281/ZENODO.51062","DOIUrl":"https://doi.org/10.5281/ZENODO.51062","url":null,"abstract":"Objective: A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Mesalazine and Rifaximin in synthetic mixture using Simultaneous Equation Method. Objective of the study was to deliver information related to Mesalazine and Rifaximin combination’s analytical method. Methods: The absorbance was measured at 328 nm for Mesalazine and 292 nm for Rifaximin and calibration curves were plotted as absorbance versus concentration, respectively. The method was found to be linear (r 2 > 0.999) in the range of 10-50 μg/ml for Mesalazine at 328 nm. The linear correlation was obtained (r 2 > 0.999) in the range of 10-50 μg/ml for Rifaximin at 292 nm. Results: The limit of determination (LOD) was 0.215 μg/ml and 0.214μg/ml for Mesalazine and Rifaximin respectively. The limit of quantification (LOQ) was 0.652 μg/ml and 0.648 μg/ml for Mesalazine and Rifaximin respectively. The accuracy of this method was evaluated by recovery studies and good recovery results were obtained greater than 99%. The method was successfully applied for simultaneous determination of Mesalazine and Rifaximin in binary mixture. Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which is considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91434623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Rai, S. Chandra, Shashi Pratap Singh, A. Parveen
Atherosclerosis is an inflammatory disease. Because high plasma concentrations of cholesterol, in particular those of low-density lipoprotein (LDL) cholesterol, are one of the principal risk factors for atherosclerosis, the process of atherogenesis has been considered by many to consist largely of the accumulation of lipids within the artery wall; however, it is much more than that. The lesions of atherosclerosis occur principally in large and medium-sized elastic and muscular arteries and can lead to ischemia of the heart, brain, or extremities, resulting in infarction. They may be present throughout a person’s lifetime. Among patients with established cardiovascular disease, mortality is lower among those who participate in an exercise program than among those who do not. Furthermore, recent studies have reported positive lipid-lowering effects from estrogen and/or progestogen in postmenopausal women but there are still conflicting reports on the use of these agents in dyslipidaemia and in females at risk for CHD. In addition to lowering lipid levels, these antihyperlipidaemic The new therapeutic options available to clinicians treating dyslipidaemia in the last decade have enabled effective treatment for many atherosclerotic process.
{"title":"Atherosclerosis: a life changing phenomenon","authors":"A. Rai, S. Chandra, Shashi Pratap Singh, A. Parveen","doi":"10.5281/ZENODO.51058","DOIUrl":"https://doi.org/10.5281/ZENODO.51058","url":null,"abstract":"Atherosclerosis is an inflammatory disease. Because high plasma concentrations of cholesterol, in particular those of low-density lipoprotein (LDL) cholesterol, are one of the principal risk factors for atherosclerosis, the process of atherogenesis has been considered by many to consist largely of the accumulation of lipids within the artery wall; however, it is much more than that. The lesions of atherosclerosis occur principally in large and medium-sized elastic and muscular arteries and can lead to ischemia of the heart, brain, or extremities, resulting in infarction. They may be present throughout a person’s lifetime. Among patients with established cardiovascular disease, mortality is lower among those who participate in an exercise program than among those who do not. Furthermore, recent studies have reported positive lipid-lowering effects from estrogen and/or progestogen in postmenopausal women but there are still conflicting reports on the use of these agents in dyslipidaemia and in females at risk for CHD. In addition to lowering lipid levels, these antihyperlipidaemic The new therapeutic options available to clinicians treating dyslipidaemia in the last decade have enabled effective treatment for many atherosclerotic process.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78633072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: The main purpose of this study is to analyse and determine the opinion of a group of pharmacists who are the owners or shareholders in the Sudanese medicine importing companies and their perception concerning the effects of the government’s new Pharmacy, Poisons, Cosmetics and Medical Devices Act has had on the quality of medicines in Sudan. Methods: The study proposal was discussed to identify and improve the quality of medicines in Sudan. The survey was deliberately drug importers biased, as low quality medicines from informal sources will affect their business. The author then designed a self-administered questionnaire of 14 close-ended questions and one open question. Results: 93% of participants either strongly agree (73%) or agree (20%) the increased number of non-registered medicines distributors will facilitate the marketing of low quality medicines. Nearly three-quarters (71%) agreed the pre-marketing surveillance is not enough to ensure the quality of medicines. The law regulating medicines was judged by the respondents as generally adequate (68%). Conclusions: The study reveals the need for further research to find out how efficient the regulatory authorities at both federal and state levels are. The research also needed to discover whether or not counterfeit medicines are sold on the Sudanese market.
{"title":"Counterfeit drugs set alarm bells ringing: comparative analysis of drug policies","authors":"A. Omer","doi":"10.14196/SJR.V5I1.2116","DOIUrl":"https://doi.org/10.14196/SJR.V5I1.2116","url":null,"abstract":"Objective: The main purpose of this study is to analyse and determine the opinion of a group of pharmacists who are the owners or shareholders in the Sudanese medicine importing companies and their perception concerning the effects of the government’s new Pharmacy, Poisons, Cosmetics and Medical Devices Act has had on the quality of medicines in Sudan. Methods: The study proposal was discussed to identify and improve the quality of medicines in Sudan. The survey was deliberately drug importers biased, as low quality medicines from informal sources will affect their business. The author then designed a self-administered questionnaire of 14 close-ended questions and one open question. Results: 93% of participants either strongly agree (73%) or agree (20%) the increased number of non-registered medicines distributors will facilitate the marketing of low quality medicines. Nearly three-quarters (71%) agreed the pre-marketing surveillance is not enough to ensure the quality of medicines. The law regulating medicines was judged by the respondents as generally adequate (68%). Conclusions: The study reveals the need for further research to find out how efficient the regulatory authorities at both federal and state levels are. The research also needed to discover whether or not counterfeit medicines are sold on the Sudanese market.","PeriodicalId":19998,"journal":{"name":"Pharmaceutical and Biological Evaluations","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82009325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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