CURRENT STATUS, CHALLENGES AND PREVENTIVE STRATEGIES TO OVERCOME DATA INTEGRITY ISSUES IN THE PHARMACEUTICAL INDUSTRY

The pharmaceutical industry is currently one of the most dynamic among all industries. At present, it is striking with various compliance challenges like never before there is increased regulation, acquisitions, push toward harmonization and endemic in a Data Integrity (DI) concern. DI weakness is identified, either as a result of an audit or a regulatory inspection, companies with multiple sites should ensure that appropriate corrective and preventive actions are implemented across the organizations and appropriate notification to regulatory authorities should be made wherever applicable. The objective of the study carries the number of issues involved within data integrity in current GMP aspects, the root causes were addressed based on warning letters. This review intends to study the concept of data integrity holistically in all aspects, regulatory expectations and to evaluate the state of compliance and challenges that explore to suggest appropriate remedial and proactive measures to avoid DI issues. There were many challenges involved to overcome the issues, which are all about the one's handling by maintaining good documentation practice. The importance, strategies and recommendations were discussed to overcome from the repeated data integrity mistakes. This review was carried out by systematic searches of data integrity in relevant guidelines, published articles, reviews and abstracts in Google scholar, Pubmed, Science direct, Embase, Web of science, Cochrane database of systematic reviews of articles up to March 2020. The keywords used for gathering information were listed below

PHARMACY PROFESSIONS IN INDIADURING COVID-19 PANDEMIC: PRESENT STATUS, FUTURE CHALLENGES AND A WAY FORWARD

People in every country became exposed to COVID-19 pandemic and cannot able to find a right solution and strategies to overcome from it. Pharmacy is the most important, dynamic and versatile health care profession in the world, whereas its scope and importance are always being emerging at any situation. Pharmacy professionals (PPs) working proactively for the public even in this pandemic situation. Since dependency is high, the responsibility and preference also high for PPs especially in this pandemic situation. Current status in pharmacy education and emerging future challenges of PPs in all aspects, particularly in thispandemic situation were addressed based on observational studies among various pharma industries and published news of Pharmacy Council of India (PCI). While in the development phase it has crossed many barriers, not only in the economic level,but also involves regulations, duration, process controls, legal hurdles and situational defects. The purpose of this review discusses the evolution and updates in pharmacy, education, pharmacy practice, regulations, and types of challenges along with recommendations for PPs in India in light of the COVID-19 pandemic. This review was carried out to summarize knowledge about the updates and challenges in pharmacy professions in all aspects. Sources were retrieved from relevant guidelines and published articles in Google scholar, Pubmed and Science direct of articles up to June 2020. The keywords used for gathering information were listed below

Comparison of PSO and GA for K-Node Set Reliability Optimization of a Distributed System

Particle Swarm Optimization (PSO), as a novel evolutionary computing technique, has succeeded in many continuous problems, but quite a little research on discrete problem especially combinatorial optimization problem has been reported. In this paper, a discrete PSO algorithm is proposed to solve a typical combinatorial optimization problem: K-Node Set Reliability (KNR) optimization of a distributed computing system (DCS) which is a well-known NP-hard problem is presented. It computes the reliability of a subset of network nodes of a DCS such that the reliability is maximized and specified capacity constraint is satisfied. The feasibility of the proposed algorithm is demonstrated on 8 nodes 11 links DCS topology. The test results are compared with those obtained by the genetic algorithm (GA) method in terms of solution quality and convergence characteristics. Experimental study shows that the proposed PSO algorithm can achieve good results

Case report of total hip replacement in an amputatee

Total hip replacement (THR) in an ipsilateral neck of femur fracture is an unusual situation. Hip fractures are a common source of morbidity and mortality worldwide. Nevertheless, the discovery and development of hip arthroplasty has improved its prognosis, with a high survival rate and satisfactory functional results. Although total hip replacement has been well described in the literature especially for healthy individuals, we found only few pieces of information about the technical characteristics and results of this procedure in patients with lower extremity amputation. There were few previous case reports in the literature that describe total hip replacement (THR) in above-knee amputees and this was the first case to be done in our institute. We presented a case involving an above knee amputee (AKA) who sustained an ipsilateral neck of femur fracture. Our patient underwent a THR with a satisfactory post-operative outcome. Technical considerations for AKAs undergoing THR also are reviewed in this article

DEVELOPMENT OF OSMOTICALLY CONTROLLED ORAL DRUG DELIVERY SYSTEM FOR NATEGLINIDE AN ANTI-DIABETIC DRUG

Objective: The purpose of the present study was to develop an oral push-pull osmotic drug delivery system for the drug Nateglinide which is a bio pharmaceutics classification system (BCS) class II drug. Methods: The tablets were prepared by the wet granulation method using ingredients microcrystalline cellulose (Adsorbent), potassium chloride (Osmotic agent), poly ethylene glycol (4000 and 6000) (Hydrophilic polymer, Plasticizer), starch (Disintegrant), and aerosil. The granules were compacted by double compression method and were coated with eudragit by dipping method. Different batches were prepared to study the effect of the various ingredients and their effect on the release of the drug from the system by varying the concentrations of the ingredients in each batch. Dissolution was assessed using USP dissolution apparatus 2 in phosphate buffer pH 6.8 for 12 h. Results: Certain key findings observed includes a decrease in micro crystalline cellulose content reduced the release of the drug due to the reduction of the hydrophilic content in the tablet which complements the uptake of water from the surroundings, and increase in the ethylene glycol leads to decrease in the release which resulted due to excess swelling and increase in the osmotic agent concentration lead to satisfactory release of the drug and followed zero-order release. Conclusion: To conclude, the push-pull osmotic tablet of Nateglinide was able to deliver the drug in a controlled pattern for a prolonged period of time. This type of formulation can be used in conditions like hyperglycemia where the patient compliance can improve by reducing the dosing frequency and the plasma drug levels can be maintained, the total drug load is also reduced so that the dose related side-effects are also reduced. Keywords: Controlled release, Push-pull osmotic pump, Nateglinid

Chemical synthesis of d(GC)<SUB>4</SUB>,d(GC)<SUB>5</SUB> and d(GGTGGACCTC) by continuous flow solid phase phosphotriester method

A simplified protocol for the synthesis of oligodeoxyribonucleotides by phosphotriester approach on controlled pore glass resins using a manualdna synthesiser is presented. The main features of this method are: (i) a single system of solvents (acetonitrile:dichloromethane, 8 : 2) is used in the assembly procedure reducing the number of mechanical manipulations, (ii) dichloroacetic acid is used as a good compromise between the efficiency of deprotection and minimal depurination and (iii) it competes effectively with the phosphite method in terms of speed, efficiency and ease. All the required protected mononucleotides and functionalised resins were home-made and detailed procedures are reported. The utility of the procedure is demonstrated by the actual synthesis of sequences d(G-C)4, d(G-C)5 and d(GGTGGACCTC) required for biophysical studies in our laboratory. The oligonucleotides were purified by the recently introduced method of fast protein liquid chromatography which gives good resolutions in shorter time periods as compared to the high performance liquid chromatography technique

Effective interventional approach to control anaemia in pregnant women

Anaemia in pregnancy and low birth weight babies, a serious public health problem, troubles India and several other nations. This article reports the results of a approach to address the issue. Women up to 20 week pregnancy with haemoglobin (Hb) 9.0 g/dl or less, those with urinary fluoride beyond 1.0 mg/l and not suffering from any other ailments, were selected. Out of the 205 pregnant women attending antenatal clinics (ANCs) during 1st and 2nd trimesters, the sample and control groups were selected through computerized random sampling procedure. Ninety pregnant women formed the sample group and 115 formed the control group. The sample group was introduced to two interventions, viz.: (1) removal of fluoride from ingestion through drinking water, food and other sources, (2) counselling based intake of essential nutrients, viz. calcium, iron, folic acid, vitamins C, E and other antioxidants through dairy products, vegetables and fruits. No intervention was introduced for the control group. Sample and control groups were monitored for urinary fluoride and Hb until delivery during their visits to ANC. Birth weight of the babies were recorded from the labour room register. Results reveal that (1) the urine fluoride levels decreased in 67% and 53% of the pregnant women respectively, who attended ANCs during 1st and 2nd trimester of pregnancy. (2) An increase in Hb upon withdrawal of fluoride followed by nutritional intervention in 73% and 83% respectively has also been recorded. (3) Body mass index (BMI) also enhanced. (4) The percentage of pre-term deliveries was decreased in sample group compared to control. (5) Birth weight of babies enhanced in 80% and 77% in sample group women who attended ANC in 1st and 2nd trimester respectively as opposed to 49% and 47% respectively in the control group. (6) The number of low birth weight babies was reduced to 20% and 23% respectively in sample as opposed to 51% and 53% in control groups

Homologous recombination in mycobacteria

In recent years, considerable effort and resources have been expended to develop targeted gene delivery methods, and generation of auxotrophic mutants of mycobacteria. The results of these studies suggest that mycobacteria exhibit a wide range of recombination rates, which vary from loci to loci. Here we review the methods developed for allele exchange and targeted gene disruption as well as the mechanistic aspects of homologous recombination in mycobacteria. The results of whole genome, functional and structural analyses of Mycobacterium tuberculosis and Mycobacterium smegmatis RecA and SSB proteins provide insights into variations of the prototypic Escherichia coli paradigm. This variation of a common theme might allow mycobacteria to function in their natural but complex physiological environments

Anti-inflammatory and analgesic activity of different fractions of Boswellia serrata

The study was designed to investigate the anti-inflammatory and analgesic effect of different fractions of Boswellia serrata. The effect of different fractions of Boswellia serrata were studied using carrageenan induced paw edema, acetic acid induced writhing response, formalin induced pain, hot plate and tail flick method for studying anti-inflammatory and analgesic activity, respectively. The different fractions of B. serrata, essential oil (10 ml/kg), gum (100 mg/kg, resin (100 mg/kg) oleo-resin (100 mg/kg) and oleo-gum-resin (100 mg/kg) significantly reduces carrageenan induced inflammation in rats and shows analgesic activity, as determined by acetic acid induced writhing response, formalin induced pain, hot plate and tail flick method. The different fractions of B. serrata showed prompt anti-inflammatory and analgesic activity due to the inhibition of 5-lipoxygenase enzyme.Keywords: Analgesic; Boswellia serrata; Inflammation; 5- lipoxygenase; Burseraceae

RADIOPROTECTIVE ACTIVITY OF FICUS RACEMOSA ETHANOL EXTRACT AGAINST ELECTRON BEAM INDUCED DNA DAMAGE IN VITRO, IN VIVO AND IN SILICO

Objective: To investigate the radioprotective effect of Ficus racemosa (Fr) ethanol stem bark extract against electron beam radiation (EBR) induced DNA damage using in vitro, in vivo and in silico models.Methods: The extract of Fr was tested against radiation induced DNA damage by exposing pBR322 plasmid to different EBR dose rates. Comet assay was conducted using mice which were exposed at 6Gy EBR. In silico study was performed by inhibiting p53 protein C-chain (1TUP C) using phyto chemicals of Fr.Results: The in vitro results revealed that, Fr at lower concentration (50µg) showed inhibitory effect on radiation induced DNA damage compared with control. Exposure of mice to 6Gy EBR increased comet parameters like TL (Tail length), OTM (Olive tail moment) and %T (percentage of DNA in the tail) of blood lymphocytes. Fr ethanol extract given orally prior to irradiation at a dose of 400 mg/kg body weight protected the DNA from the radiation damage. The phytochemicals of Fr showed clear interaction with p53 protein chain C, specifically binding to Arginine 248 (ARG248) and Arginine 273 (ARG273) amino acid residues thereby inhibiting the p53 protein-DNA interaction upon radiation.Conclusion: The present study indicates that Fr ethanol extract significantly reduced radiation induced DNA damage in vivo and in vitro. It also showed that the biologically active compounds of Fr have ability to inhibit wild p53 protein which is responsible for apoptosis; these compounds can be used as radioprotectors during chemotherapy to protect normal tissues surrounding cancerous tissue.Â