Pharmacy

Treatments with biologics drugs have become the order of the day for many diseases and ailments including cancer. Unlike the availability of small molecule generics at lower costs, generic versions of biologics are not available at costs that are affordable to the patients in the developing countries. This is mainly due to factors such as immunogenicity, interchangeability, and difficulties in the manufacturing and characterisation of these biosimilars. These factors also raise a question on the conductance of pharmacovigilance programme, since each version of biologic is different. In this review, we analyse the major issues and the regulatory mandates concerning biosimilars and discuss some recommendations for the pharmacovigilance programme.

Tabernaemontana divaricata (L) R. Br. (Apocynaceae) commonly known as Tagar in Bengali. It is a garden plant in tropical countries and found throughout the Indian subcontinent. The present investigation assessed the scavenging potential by 1, 1-diphenyl-2-picryl-hydrazyl (DPPH) assay. All of the extracts exhibited potent in vitro free radical scavenging activity that increased with extract concentrations. The methanol extract was found to be the most potent in this regard, followed by the benzene and ethyl acetate extracts. Therefore, the present study confirms marked in vitro free radical scavenging activity Tabernaemontana divaricata leaves.

Ketoprofen, an anti-inflammatory drug, exhibits poor water solubility and flow properties, poor dissolution and poor wetting. Consequently, the aim of this study was to improve the dissolution of ketoprofen. Microparticles containing ketoprofen were produced by spray drying and spray chilling technology to enhance dissolution rate. The prepared formulations were evaluated for in vitro dissolution and solubility. The produced drug particles were characterized by scanning electron microscopy (SEM), differential scanning calorimeter (DSC), x-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FT-IR). Dissolution profile of the spray dried micropartical was compared with chilled spray micropartical, pure sample and recrystallized sample. Spray dried micropartical exhibited decreased crystallinity, but for spray chilled particles there was evidence of polymorphic changes in the drug and improved micromeritic properties. The dissolution of the Spray dried micropartical was improved compared with spray chilling micropartical, recrystallized and pure sample. Consequently, it is believed that spray drying of Ketoprofen is a useful tool to improve wettability, solubility and hence the dissolution behavior of poorly water soluble drugs, in contrast to spray chilling technique.

A simple, precise, accurate and rapid high-performance thin-layer chromatographic method has been developed and validated for the estimation of Montelukast sodium and Levocetrizine Hydrochloride simultaneously in combined dosage forms. The stationary phase used was precoated silica gel 60F 254. The mobile phase used was a mixture of Chloroform: Benzene: Methanol: Toluene (5:7.2:1:0.2 v/v/v/v). The detection of spots was carried out at 286 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 500-1500 ng spot-1 for Montelukast sodium 1000-5000 ng spot-1 for Levocetrizine Hydrochloride. The limit of detection and the limit of quantification for Montelukast sodium were found to be 170 ng/spot and 570 ng/spot respectively, for Levocetrizine Hydrochloride and Levocetrizine Hydrochloride, 20 ng/spot and 70 ng/spot respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.

In this study chloroform and methanol extracts of Ziziphus xylopyrus stem barks were tested for analgesic (Hot plate, Tail immersion and Acetic acid- induced writhing method) and anti-inflammatory activity (paw edema induced by carrageenan) in mice and rats, respectively. The methanolic extract in doses of 50, 100 and 200 mg/kg showed 10.91, 34.95 and 57.61 percentage of protection from writhing respectively and the percentage inhibition of paw edema at the end of four hours was 1.26, 24.05 and 35.42 respectively. In the Hot plate and Tail immersion models, methanolic extract in the above doses increased the pain threshold significantly after 30 min, 1, 2 and 3h of administration. Methanolic extract showed dose-dependent action in all the experimental models in different doses whereas chloroform extract was not able to show such remarkable significant activities.

Duloxetine, a medication with effects on both serotonin and noradrenaline transporter molecules, has recently been approved for the treatment of generalized anxiety disorder. Thus, the aim of the present study was to synthesis and formulates enteric coated pellets for delayed release and to characterise the physico-chemical property and dissolution. Duloxetin was prepared by photochemical reaction of n-bromo succinamide in carbon tetra chloride in the presence of catalytic amount of benzoyl peroxide. The prepared Duloxetine hydrochloride powder was then blended with mannitol and disodium hydrogen phosphate and sieved through 250 micron screen mesh to prepare dusting powder. It is then formulated as pellets which were seal coated by HPMC 5 cps. Further this seal coated pellets were enteric coated by using Eudragit L 30 D 55 (ammonio methacrylate copolymer dispersion), talc, triethyl citrate, titanium dioxide and purified water with the use of silversten stirrer (UK). The prepared formulations were characterized by scanning electron microscopy, differential scanning calorimeter, X-ray diffraction and Fourier transform infrared spectroscopy. Dissolution profile of the enteric coated pellets was compared with its recrystallized sample and pure sample. The samples were stored in stability chamber to investigate their physical stability. In stability test, the release profile of the pellets was almost unchanged as compared with the freshly prepared pellets stored at 40 0C and 75% relative humidity for 90 days. Hence these pellets can be formulated for giving Duloxetine hydrochloride as a delayed released formulation.

Metoprolol is an anti hypertensive and also used in the treatment of arrhythmiasis. Owing to its extensive first pass metabolism, short biological half life and multiple daily dosing, Metoprolol lends itself as an ideal candidate for development of once a day extended release (ER) formulation. Metoprolol succinate ER pellets are prepared by employing various pelletization techniques such as powder layering, extrusion & spherodization and wurster process, ethylcellulose as a release modifier and polyethylene glycol as plasticizer. Optimized pellets are compressed in to tablets. The formulation evaluated for dissolution and 7%w/w Ethyl cellulose and 15% of plasticizer met with the predetermined specification. All the formulations followed first order kinetics and mechanism of drug release is non-fickian diffusion.

This study was conducted to evaluation of satisfaction with using Sheliver cleansing distilled product in fatty liver patients. A validated questionnaire for fatty liver disease was utilized to assess for a relationship between using Sheliver liver cleanser distilled with disease remission. A total of 120 patients responded to the questionnaire. This herbal medication included extract of Borago officinalis, Taraxacum officirale, Silybum marianum, Cynara scoolymus etc and produced by Parsiteb Company. Consumption of this product is 100 ml per day. According to questionnaire it was determined that, 78%, patients showed Satisfaction in relation to appearance and packaging of product and medication effect value. 67% of patients had “good” answer about satisfaction of healing period, but one of the things that patients were dissatisfied with the product price. According to our results and patients, Sheliver product made by Parsiteb Company is the best choice for fatty liver disease in compare to chemical medications.Key words: Fatty liver, Sheliver , questionnaire

The topical route of administration is more effective route as compared to the oral route in the treatment of fungal infections of nail. The formulation objective was to provide a sustained release of antifungal drug over extended period of time, so as to reduce frequency of administration, improve clinical efficacy and improve patient compliance. The purpose of the present study was to formulate Ketoconazole nail lacquer containing two different penetration enhancers, for the treatment of onychomycosis and to find out which concentration of penetration enhancers gave better release of the drug. The formulation showed good non-volatile content, gloss, smoothness of flow, drug release, drug content estimation and antifungal activity. The in vitro studies were carried out in Franz diffusion cell using saline phosphate buffer (pH 7.4) as medium. Whereas the permeation studies were carried out using hooves membrane. The percentage cumulative drug released was determined by UV spectrophotometer. The formulation containing ethyl cellulose (10%w/v) and Thioglycolic acid (3%v/v) and Dimethyl sulfoxide (3%v/v) showed highest release of drug. FTIR studies revealed that drug and excipients are compatible. Stability studies was done as per ICH guidelines for 1 month, which revealed no significant change with respect to the evaluations conducted before stability charging. The sensitivity of Fluconazole against Candida albicans was determined by measuring zone of inhibition by comparing with the standard drug for onychomycosis treatment.

Valid information on causes of death is a vital tool to the development of national and international health policies for prevention, better management, and control of diseases and complications. World health statistics indicated that Nigeria has the highest number of people living with diabetes in sub-Saharan Africa. Many life-threatening complications arise from type 2 diabetes mellitus (DM) from which many people die annually. This study assessed the current trends in mortality among type 2 diabetes patients to provide evidence based information on the dynamics of the disease for better case management and prevention of complications. The study was a cross-sectional retrospective descriptive study of dead type 2 diabetes patients using the death register and postmortem reports. Key data were extracted from death registers and analyzed with SPSS version 20 using descriptive and inferential statistics at a significant level of p<0.05. All the 229 and 91 deaths in NAUTH and ANSUTH due to DM complications were recorded. Diabetic foot ulcer (DFU) had the highest mean percentage death (51.9%). Diabetic ketoacidosis, hypertension, and hyperglycemia were implicated. Married patients had the highest cases of DM mortality 173(75.6%) for NAUTH and 52(57.2%) for ANSUTH. Type 2 DM is a major cause of morbidity and mortality worldwide and the associated burden is more prevalent in developing countries. Studies have shown that DFU with: infection, sepsis, DKA, hyperglycemia, and hypertension are very important complications among T2DM in Nigeria.