Regulatory strategies for drug product registration in North African Countries
Regulatory requirements for various countries of world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can simultaneously submitted in all countries for approval. Africa is the second fastest growing pharmaceutical market in the world and is driven by a small number of countries like south-Africa, Nigeria, Ghana, East-Africa, North Africa. During the past decade, the African continent has been home to some of the fastest-growing economies in the world, creating a large window of opportunity for the development of the pharmaceutical sector. Africa’s pharmaceutical sector was expected to reach about 30 billion US Dollars by 2016. The main objective of this study is to discuss about the various parameters and requirements for Registration of externally developed pharmaceutical products in North Africa for Approval. Pre-Requisite knowledge of country specific Guidelines and norms is very important to analyse the similarities and differences between the regulatory requirements of different countries. The Pharmaceutical Market in Africa is growing fast at a Compound annual growth rate (CAGR) of 10.6%. The value of Africa’s pharmaceutical industry jumped to $20.8 billion in 2013 from just $4.7 billion a decade earlier. That growth is continuing at a rapid pace: the market will be worth $40 billion to $65 billion by 2020. The purpose of this study is to focus on the key assessment parameters required for developing a pharmaceutical product so that it can be simultaneously registered in numerous African countries for approval.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Minocycline in brain- a bench to bed side view
Originally developed as an antibiotic Minocycline has shown a variety of aspects that makes Minocycline a versatile molecule with diversified roles. Beside an antibiotic it has proven to be beneficial in different disorders and the potential of Minocycline to attenuate the severity of disease like stroke, cerebral ischemia, multiple sclerosis, spinal-cord injury, Parkinson’s disease, epeilepsy, traumatic brain injury, Huntington’s disease, and amyotrophic lateral sclerosis and Alzheimer’s disease makes it a centre of fascination in research circles. Despite progress in understanding the pathogenesis of several neurological disorders, our knowledge of the mechanisms leading to neuronal cell loss, glial dysfunction, and vascular remodeling is incomplete. In this review, we describe the evidences and various mechanisms which may be responsible for the efficacy of Minocycline in several neurological disorders and introduce the emerging investigation of minocycline in clinical neurology. The encouraging results of minocycline in experimental neurology make it a potential therapeutic target in human neurological diseas
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Induction of apoptosis in Hela cells by ethanolic extract of Skeletonema costatum
Marine organisms are rich sources of new, biologically active compounds. Phytoplanktons have traditionally been used as foods. Algal powder as a food supplement for prevention or therapy of bacterial fish disease. Recently, much attention has been paid to the anticancer activity of Phytoplankton. Thus, we have screened organic extracts of Phytoplankton for their anticancer activity against human cancer cell line, and selected Skeletonema costatum as a candidate for use in treatment. The ethanolic extracts of Skeletonema costatum (EESC) showed cytotoxic activity against human cervical adenocarcinoma cell line, (HeLa). The IC50 of EESC against the HeLa cells was 250 µg/ml. Treatment of HeLa cells with various concentrations of EESC resulted in growth inhibition and induction of apoptosis in a dose-dependent manner. These results strongly suggest that EESC may be a potential candidate in the field of anticancer drug discovery.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Proniosomes: a preferable carrier for drug delivery system
In recent time, proniosomal and noisomal system have been received a great attention in drug delivery applications as well as in pharmaceutical research. In order to minimize the problems associated with niosome physical stability such as aggregation, fusion and leaking and to provide additional convenience in transportation, distribution, storage and dosing etc, a dry product can be prepared, which is called proniosome. Proniosomes are dry formulation using suitable carrier coated with nonionic surfactants and can be converted into niosomes immediately before use by hydration. These proniosome-derived niosomes are as good as or even better than conventional niosomes. The current review deals with the trends, different aspects and the future perspective in the development of proniosomal drug delivery systems.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
A Review on Non Allopathic Treatment in Migraine
Headache is one of the most common complaints encountered by healthcare practitioners, accounting for more than 1% of visits to physicians’ offices or emergency departments. As one of the top 10 presenting complaints in ambulatory medical care, headache can be symptomatic of a distinct pathologic process or can occur without an underlying cause. A migraine is caused by abnormal brain activity, which can be triggered by a number of factors. However, the exact chain of events remains unclear. Today, most medical experts believe the attack begins in the brain, and involves nerve pathways and chemicals. The changes affect blood flow in the brain and surrounding tissues. Caffeine withdrawal, Changes in hormone levels during a woman's menstrual cycle or with the use of birth control pills, Changes in sleep patterns, Exercise or other physical stress, Missed meals, Smoking or exposure to smoke. Migraine is an incurable disease. The review study was undertaken with the intention of finding a remedy for migraine. Preventive treatments of migraines include medications, nutritional supplements, lifestyle alterations, and surgery. Prevention is recommended in those who have headaches more than two days a week, cannot tolerate the medications used to treat acute attacks, or those with severe attacks that are not easily controlled.The goal of migraine therapy is to reduce the frequency, painfulness, and/or duration of migraines, and to increase the effectiveness of abortive therapy and to reduce drug consumption.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Recent trends in diagnosis criteria, clinical features and management diabetic neuropathy-a nerve disease
Diabetic neuropathy is a type of nerve damage that is seen in people who have diabetes. This makes it difficult for the nerves to carry messages to the brain and parts of the body. Diabetic neuropathy can result in numbness or painful tingling in different parts of the body. Diabetic neuropathy can affect any part of the nervous system. This nerve disorder should be suspected in all patients with type 2 diabetes and in patients who have had type 1 diabetes for more than five years. About 60 to 70 percent of people with diabetes have some form of neuropathy. People with diabetes can develop nerve problems at any time, but the risk increases with age and duration of the disease. The highest rates of neuropathy occur among people who have had diabetes for at least 25 years and among people who have trouble controlling their blood sugar levels, as well as those with high levels of blood fat and blood pressure and those who are overweight. Diabetic neuropathy is long-term damage to the nerve fibres. It happens when high blood glucose levels are present over several years. In diabetes, the form it usually first takes is reduced sensation in the feet. The nerve damage affects each foot equally and eventually spreads up the legs. Poor sensation in your feet makes them more prone to injury. Combined with poor circulation this can easily lead to ulcers and infections. As community Pharmacist becomes a consultant for patients who are put on therapy. He counsels the patients about the disease process and simultaneously role of drugs. He informs the patient of drug interations and adverse reactions.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Spectrophotometric methods for the quantitative estimation of paliperidone in formulations
Two simple, sensitive and economical spectrophotometric methods have been developed and validated for the determination of Paliperidone in pharmaceutical dosage forms. The methods were based on the formation of colored complex of Paliperidone with different reagents. The absorbance of the formed color complex is measured at the wavelength of maximum absorbance of the complex against the reagent blank treated similarly. These methods have different linearity ranges observed in the concentration ranges of 8 – 28 and 4 – 14 ?g/mL with correlation coefficients 0.9995 and 0.9998 respectively. Statistical analysis proves that the proposed methods are reproducible and selective for the estimation of Paliperidone in bulk drug and in its tablet dosage form.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Protein misfolding and neurodegeneration; new approaches to combat toxic misfolded proteins
Important molecular pathways implicated in diverse neurodegenerative diseases are the misfolding, aggregation, and accumulation of the proteins in the brain. Accumulation and misfolding of proteins leads to synaptic dysfunction, neuronal apoptosis, brain damage and disease. The mechanisms which lead to protein misfolding and subsequent neurodegeneration are not clearly understood. The techniques for combating neurodegeneration due to toxic proteins are being investigated. The approach can be two pronged i.e to either do the gene repair using novel techniques like the usage of peptide nucleic acid or to alter the sensitivity or conformation of the receptor proteins or enhancement of enzymes responsible for degradation of these misfolded proteins for e.g ubiquitin-proteosome.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Medical Device Warning Letters: Trend analysis from 2011 to 2016
The medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year among other revolutionized technologies. The USFDA’s Center for Devices and Radiological Health (USFDA/CDRH) governs the Regulatory oversight of the medical devices. This article presents a summary of the Warning Letters issued for medical devices by USFDA from 2011 to 2016 and a trend analysis and statistics were made, which demonstrates a clear picture of the number of Warning Letters issued for 10 categories of Medical Devices. This was done to highlight the special issues that were observed. By comparing this data to that of the recent fiscal years, Pharmaceutical and Medical Devices manufacturing firms can gain a fair picture of the FDA enforcement trends and their probable impact on both Business and industry. The study found that the implementation of quality improvement strategies such as Six sigma, Quality by Design (QbD), Total Quality Management (TQM) can minimize the number of deviations and defects which leads to reduction in 483 observations and FDA Warning Letters.: It was found that739 Warning Letters for medical devices were issued by USFDA for FYs 2011 to 2016, wherein the FY 2012 (171) issuance was more and least in 2016 (43). Adulteration and failure to implement CAPA were the major deficiencies for which the Warning Letters were issued and the number has declined by 2016.
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]
Serum selenium, glycemic control and blood lipoproteins in type 2 diabetes mellitus
The present study determined serum selenium, blood glucose, Glycosylated HbA1, and blood lipoprotein in diagnosed cases of type 2 Diabetes mellitus subjects (T2DM). Place and Duration: Department of Medicine, Liaquat University Hospital Jamshoro/Hyderabad from January 2015 to February 2016. Subject & Methods: A sample of 350 T2DM was selected through non probability purposive sampling according to inclusion and exclusion criteria. Blood glucose, HbA1c, serum triglycerides (TAG), total cholesterol (TC), VLDL, LDLc, and HDLc were estimated. Serum selenium was measured by atomic absorption technique. The Data was analyzed by SPSS 22.0 (USA) using appropriate statistical tests at 95% confidence interval. Results: Serum selenium deficiency was observed in 229 (65.4%) of cases. Serum selenium in normal (?70µg/L) and deficient (<70µg/L) was noted as 97.7± 1.29 and 63.9± 4.7 µg/L respectively (p=0.0001). Serum selenium showed negative correlation with TAG, TC, LDLc, VLDL, blood glucose and glycosylated HbA1. Conclusion: The present study reports serum selenium deficiency in majority of type 2 diabetics. Serum selenium showed negative correlation with TAG, TC, LDLc, VLDL, blood glucose and Glycosylated HbA1. Key words: Type 2 DM Serum selenium Glycemic control Dyslipidemia
Please Login using your Registered Email ID and Password to download this PDF.
This article is not included in your organization's subscription.The requested content cannot be downloaded.Please contact Journal office.Click the Close button to further process.
[PDF]