• Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines

      Technology transfer in simple terms transfer of the technology in the form of idea, innovation and process etc. for successful technology transfer there is an involvement of the two sites together with its documentation. Here this review paper describes various models proposed for the technology transfer such as qualitative model and quantitative models and there requirements, and it also includes basic principle and goals for the technology transfer. Download
    • Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines

      Technology transfer in simple terms transfer of the technology in the form of idea, innovation and process etc. for successful technology transfer there is an involvement of the two sites together with its documentation. Here this review paper describes various models proposed for the technology transfer such as qualitative model and quantitative models and there requirements, and it also includes basic principle and goals for the technology transfer. Download
    • Review On Analytical Method for Determination of Sitagliptin Phosphate in Bulk and In Different Dosage Forms

      Dipeptidyl peptidase-4 inhibitors (DPP-4s), also called as gliptins, are a relatively new class of drugs to treat type 2 diabetes. Sitagliptin phosphate competitively inhibit dipeptidyl peptidase-4 (DPP-4). This enzyme breakdown the incretins GLP-1, gastrointestinal hormones released in response to a meal. By preventing GLP-1 inactivation, they are able to increase the secretion of insulin and suppress the release of glucagon by the alpha cells of pancreas. This leads blood glucose level to normal. It also opens new gateways for a personalized medicine in patients with Type 2 diabetes and it also offers various merits when compared to other glucose-lowering agents. Despite they have been commercialized since a few years only, available data obtained in randomized controlled trials are of better quality compared to those available with classical glucose-lowering agents, especially in elderly people who have suffering from renal impairment or at high cardiovascular risk and patients at higher risk of hypoglycemia. But, their remaining uncertainties and controversies that should be resolved by further ongoing large prospective controlled trials and increasing clinical experience combined with a careful post-marketing surveillance. The clinical and pharmaceutical analysis of these drugs requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. There are many analytical methods reported so far in the literature for the determination of Sitagliptin phosphate in Biological samples and pharmaceutical formulations. This article narrates different chromatographic (HPLC, HPTLC, UPLC, LC) & different spectrophotometric method (UV) for Sitagliptin single drug as well as combination with other drug Download
    • RP-HPLC Method Development And Validation For Simultaneous Estimation of Artemether and Lumefantrine in Pharmaceutical Dosage Form

      The importance of Antimalarial drugs are increasing day by day & used for method development by reverse phase HPLC. In literature survey few analytical methods have been reported for determination of drug out of which some are time consuming and costly. So this research work is dedicated to develop simple, efficient, Economical, fast, reliable and new method for estimation of Selected drug. RP-HPLC analysis was performed on the Grace C-18 (250 mm × 4.6 mm), 5 µm particle size and using Acetonitrile: Potassium Phosphate buffer (60:40v/v) as mobile phase; flow rate was adjusted to 1 ml/min. The detection was carried out at 215 nm. The average retention times of Artemether and Lumefantrine was observed 8.11 min and 10.25 min at 215 nm wavelength respectively. Linearity was observed in the concentration ranges of 2–10µg/ml (r2 = 0.999) for ART and 12 - 60 µg/ml (r2 = 0.999) for LUME. The method has been successively applied for the determination of ARTEMETHER and LUMAFANTRINE in tablet formulation. There was no interference from the excipients commonly present in the tablet. Accuracy of the method was studied by the recovery studies at three different levels 80 %, 100 % and 120 % level. The % recovery was found to be within the limits of the acceptance criteria with average recovery of 97-105%. The method was found to be accurate, precise and specific for estimation of Artemether and Lumefantrine drugs in pharmaceutical dosage forms Download
    • Resealed Erythrocytes: A Novel Drug Delivery System

      Now days the research work in the drug development is mainly focusing on targeted drug delivery for better therapeutic effect. Carrier erythrocytes have been evaluated in thousands of drug administration in humans proving safety and efficacy of the treatments. Carrier erythrocytes, resealed erythrocytes loaded by a drug or other therapeutic agents, have been exploited extensively in recent years for both temporally and spatially controlled delivery of a wide variety of drugs and other bioactive agents owing to their remarkable degree of biocompatibility, biodegradability and a series of other potential advantages. Biopharmaceuticals, therapeutically significant peptides and proteins, nucleic acid-based biologicals, antigens and vaccines, are among the recently focused pharmaceuticals for being delivered using carrier erythrocytes. In this review article, the potential applications of erythrocytes in drug delivery have been reviewed with a particular stress on the studies and laboratory experiences on successful erythrocyte loading and characterization of the different classes of biopharmaceuticals. Download
    • Rationale Drug Use In Two Hospitals In Khartoum State Is There A Role For Clinical Pharmacists

      This is a prospective, observational hospital study set out to assess the need for a clinical pharmacist within the hospital. The study was conducted in two hospitals in Khartoum state, Hospital 1 and Hospital 2 during a period of 30 days. The data collected was questionnaire based from all patients attending the Medicine and Paediatric ward (n=140) in the two hospitals, consultants (n=3), registrars (n=3), housemen (n=35) and nurses (n=30). The data was analysed using statistical package of social science (SPSS) computer programme. The investigation examined the major drug use aspects with particular emphasis on the components of drug supply, storage, prescribing, dispensing and treatment monitoring. The overall results from the two hospitals were fairly in good agreement that have warranted justifiably the grounds to reach the following findings; • The main prescribers of drugs in hospitals are the housemen doctors • Lack of adequate awareness of doctors of what drugs their patients are taking or currently using. (As indicated by the discrepancy between the number on record sheet and that directly observation). • All aspects of drug use are handled by co patients. • Advice on dosage regimen aspects as well as side effects to patients was often lacking. This finding are very much indicative of the need to ensure rational medication use in its broad meaning, and area well within the role and responsibilities of a clinical pharmacist as judged by today’s globally established definition of clinical pharmacy ‘ the area of pharmacy concerned with the science and practice of rational medication use’. Download
    • Recent Developments In Insulin Delivery For The Treatment of Diabetes Mellitus

      Diabetes mellitus is a chronic lifelong condition which affects millions of people in the world. The main cause of this disease is the pancreas will not producing insulin, “a hormone which regulates blood glucose level in the body”, will leads to severe vascular complications and leads to death. The one and only way of survive against this disease is to provide exogenous insulin in our body. The conventional mode of delivering the exogenous insulin is by subcutaneous route by needles or injections which produces painful and invasive therapy leads to poor patient compliance. So various methods are developed for delivering the exogenous insulin in our body like inhaled insulin (Exubera), transdermal patch, insulin infusion pump and insulin sprays and insulin pills are available which uniform maintain blood glucose level in the body for several hours leads to increased patient compliance, So in present review we highlighted the novel methods of insulin delivery for the treatment of diabetes mellitus. Download
    • Retinoblastoma –A Molecular Dream

      Retinoblastoma is an uncommon eye tumor of adolescence that emerges in the retina. It is the most well-known intraocular distortion of childhood; with an occurrence of 1/20,000–25,000 live births. The two most recurrent manifestations uncovering retinoblastoma are leukocoria and strabismus. Iris rubeosis, hypopyon, hyphema, buphthalmia, orbital cellulites and exophthalmia might likewise be detected. Sixty five percent of retinoblastomas are unilateral and mostly are non-genetic (identified within two year). Retinoblastoma is bilateral in 35% of cases (identified within one year). All bilateral and multifocal unilateral structures are innate. Innate retinoblastoma constitutes a cancer predisposition disorder: a subject unavoidably conveying a RB1 gene mutation has 90% risk of developing retinoblastoma but on the other hand are at higher risk of developing various cancers. Identification is made by fundoscopy, Ultrasound, MRI and CT scan. Managing patients with retinoblastoma must consider the different aspects of the malady: the visual impairment, the conceivably hereditary nature of the illness and the life-time risk. Download
    • Recent Trends of Nanotechnology In Drug Delivery And Their Application-An Overview

      Controlled drug delivery systems (DDS) have several advantages compared to the traditional dosage forms. From the last few decades, there has been a considerable research on the basis of Novel drug delivery system, using particulate drug delivery systems as such drug carriers for small and large molecules. Nanoparticles, Liposomes, Microspheres, Niosomes, Pronisomes, Ethosomes, and Pro-liposomes have been used as drug carrier in vesicle drug delivery system. Various polymers have been used in the formation of Nanocarriers. Nanocarriers are colloidal particulate systems with size ranging between 10-1000 nm. This are used for the diagnosis, treatment and monitoring of various diseases and physical approach to alter and improve the pharmacokinetic and pharmacodynamics properties of various types of drug molecules. Controlled and targeted delivery is one of the most valuable requirements from a carrier, which involves multi-disciplinary site specific or targeted approach. Nanoparticulate drug delivery system may offer plenty of advantages over conventional dosage forms, which includes improved efficacy, reduced toxicity, enhanced biodistribution and improved patient compliance. Download
    • Rationale Drug Use In Two Hospitals In Khartoum State: Is There A Role For Clinical Pharmacists?

      This is a prospective, observational hospital study set out to assess the need for a clinical pharmacist within the hospital. The study was conducted in two hospitals in Khartoum state, Hospital 1 and Hospital 2 during a period of 30 days. The data collected was questionnaire based from all patients attending the Medicine and Paediatric ward (n=140) in the two hospitals, consultants (n=3), registrars (n=3), housemen (n=35) and nurses (n=30). The data was analysed using statistical package of social science (SPSS) computer programme. The investigation examined the major drug use aspects with particular emphasis on the components of drug supply, storage, prescribing, dispensing and treatment monitoring. The overall results from the two hospitals were fairly in good agreement that have warranted justifiably the grounds to reach the following findings; • The main prescribers of drugs in hospitals are the housemen doctors • Lack of adequate awareness of doctors of what drugs their patients are taking or currently using. (As indicated by the discrepancy between the number on record sheet and that directly observation). • All aspects of drug use are handled by co patients. • Advice on dosage regimen aspects as well as side effects to patients was often lacking. This finding are very much indicative of the need to ensure rational medication use in its broad meaning, and area well within the role and responsibilities of a clinical pharmacist as judged by today’s globally established definition of clinical pharmacy ‘ the area of pharmacy concerned with the science and practice of rational medication use’. Download