Cisplatin is an anticancer drug extensively used against a variety of cancers. Cisplatin chemotherapy is found to manifest dose-dependent nephrotoxicity. Depletion of the renal antioxidant defence system has been suggested to be the main cause of cisplatin-induced nephrotoxicity. The purpose of this study is to investigate whether the ethanol extract of entire plant of Sphaeranthus indicus could reduce the intensity of toxicity in albino rats. Nephrotoxicity was assessed by determining the serum creatinine and urea levels and renal antioxidant status in rats after cisplatin administration (12 mg kg(-1) body weight, i.p.). The ethanol extract of S. indicus (150 and 300 mg kg(-1) body weight) was administered orally from the sixth day onwards for 10 days after cisplatin administration. The extract significantly reduced the elevated serum creatinine and urea levels. Renal antioxidant defence systems, such as superoxide dismutase, catalase, glutathione peroxidase activities and reduced glutathione level that are depleted by cisplatin therapy were restored to normal by treatment with the extract. Cisplatin-induced lipid peroxidation was also found to be markedly reduced by treatment with the extract. These results suggest that S. indicus has protective effect against cisplatin-induced nephrotoxicity, which may be attributed to its antioxidant potential.
Aim: The objective of preformulation study is to develop the elegant, stable, effective and safe dosage form by establishing kinetic profile, compatibility with other formulation excipients and physico-chemical parameters of new drug substance. This could provide important information for formulation design or support the need for molecular modification. So, in the present study preformulation studies were performed on Glimepiride (GMP) to assess its suitability for parenteral formulation. Glimepiride is the first IIIrd generation sulphonyl urea used to treat type –II diabetes mellitus. Methods: The authenticity of GMP was established by DSC and FTIR spectra. A UV spectrophotometric method and HPLC method were employed for determination of GMP in bulk active pharmaceutical ingredient (API). Results: The UV method was linear in the range of 3-10 μg/ml. The low % CV values of intra-day and inter-day variations revealed that the proposed method is robust. The retention time of GMP in HPLC method was found to be 1.9 min. The method was proven robust by obtaining very high regression coefficient value (0.999). Conclusions: The results of the physicochemical study of drug revealed suitability of GMP for parenteral route. Moreover, the drug was found stable in both solid as well as liquid state at different conditions.
This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.
Software is becoming increasingly important in medical devices and digital adoption more broadly. It is becoming more important as a medical device in its own right. (1) Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control and clinical evaluation for SaMD. Millions of users use AI based medical device for the diagnosis & Management of diseases. Regulation for the SaMD, IMDRF published guidance document in 2013, in EU they are regulated by EMA, in Australia they are regulated by TGA and in Canada they are regulated by Health Canada. Regulations of these countries and IMDRF were reviewed and articles of challenges in artificial intelligence based medical devices reviewed. There are also many challenges like cybersecurity, safety, and decommissioning, high cost of device and also the design and development process. The objective is to focus on SaMD’s regulations and Challenges.
"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Philippines Nutraceuticals are known as food supplement & dilatory supplement. In Sudan, Nutraceuticals are known as dietary supplement & health product .In Cambodia Nutraceuticals are known as health supplement product. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.
The main objective of pre-formulation study is to develop the stable, elegant, safe and effective drug delivery system by establishing drug kinetic profile, formulation compatibility with different excipients and physico-chemical parameters of new drug molecules. This could provide key evidence for implementing formulation design or requirement of the molecular alteration. So, in the present study preformulation studies were performed on Saxagliptin Hydrochloride (SXG) to assess its suitability for parenteral formulation. SXG is a potent and selective reversible inhibitor of dipeptidyl peptidase-4 used to treat type –II diabetes mellitus. The authenticity of SXG was established by differential scanning calorimetry (DSC) and fourier transform infrared spectroscopy(FTIR) spectra. An ultraviolet–visible (UV) spectrophotometric and high performance liquid chromatography (HPLC) methods were employed for determination of SXG in bulk API (active pharmaceutical ingredient). The UV method was linear within the range of 1-40 μg/ml. The proposed methodology is robust which can be concluded from the lower percentage standard deviation percentage co efficient of variance (% CV) values of intraday and inter day variability. The retention time was observed 1.3 min of SXG in HPLC method. The higher regression coefficient value (0.999) indicates the methodology is robust.
Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.
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