JOURNAL OF DRUG DELIVERY AND THERAPEUTICS

9-16

Authors: Ganeshanand, Jeet Kamal, Ashish Baldi

Rheumatoid arthritis is an auto-immune joint disorder involving pain and inflammation. Various approaches are used for pain management and relief from arthritis with single and multiple dose therapy. In single dose therapy, use of non-steroidal anti-inflammatory drugs like diclofenac aceclofenac, celicoxib etc. reported many side effects mainly leading to decrease in production of prostaglandin and holding the ulcer. High dosing frequency of these drugs is also a major factor of risk. Recently developed novel formulations are especially suitable for achieving controlled and delayed release profile with low risk of dose dumping. These systems have received great attention of pharmaceutical industry as they deliver accurate amount of drug at the right time and location thus increasing patient compliance and economic feasibility and avoiding drug associated side effects. Present review mainly deals with the problem of ulceration in pain management, various approaches to overcome this and specifically explore the possibilities to apply novel drug delivery systems for this purpose. Keywords: Arthritis, Drug delivery systems, Gastroretentive, NSAIDs, Pain, Rheumatoid arthritis, Rheumatic pain management.

20-28

Authors: P B Dalvi, A B Gerange, P R INGALE

The solubility behavior of drugs remains one of the most exigent aspects in formulation development.With the advent of combinatorial chemistry and high throughput screening, the number of poorly water soluble compounds has dramatically increased. Among all the newly discovered chemical entities, about 40-45% drugs fail to reach market due to their poor water solubility. Because of solubility problem, bioavailability of drugs gets affected and hence solubility enhancement becomes necessary. Solid dispersions have attracted considerable interest as an efficient means of improving the dissolution rate and hence the bioavailability of drugs. This article reviews the various preparation techniques, carriers used, advantages and limitations of solid dispersions and compiles some of the recent advances. There are various methods available to improve the solubility of the new drug in which solid dispersion emerged promising. A Solid dispersion generally composed of two components- the drug and the polymer matrix. Numerous methods are existing to prepare the solid dispersions such as melting method, solvent evaporation method, fusion method, kneading method, melting method, spray drying method, co-grinding method, lyophilization technique, hot melt extrusion, melt agglomeration, supercritical fluid (SCF) technology etc. Solid dispersion technologies are particularly promising for improving the oral absorption and bioavailability of BCS Class II drugs. The experience with solid dispersions over the last 10-15 years indicates that this is a very fruitful approach in improving the release rate and oral bioavailability of poorly water soluble drugs. Hence, this approach is expected to form a basis for the commercialization of many poorly water-soluble and water-insoluble drugs in their solid-dispersion formulations in the near future. Key words: Dissolution, Solid Dispersion, Solubility, Cellulose Derivatives, Polyethylene glycol.

45-49

Authors: Mirza Atif Beg

Background: Drug utilization studies are beneficial in clinical practice for rational prescribing, as there is continuous proliferation of new drugs and the increasing recognition of their delayed adverse effects. Depression is an important global public health problem thus making such studies a must for minimizing the medication errors. Aim and objectives: Present study audits the prescribing pattern of psychiatric private practitioners (PPs) vs psychiatric practitioners of tertiary care teaching hospital (TCTH) at Dehradun, Uttarakhand. Materials and methods: A total of 371 prescriptions were analysed, 196 were from collected from PPs and 175 from TCTH at Dehradun. They were analysed using WHO drug use indicators and National List of Essential Medicines (NLEM-2013). Results: Anxiolytics 150(25.25%) were most commonly prescribed by the PPs followed by antidepressants 120(20.20%) and antipsychotics 111(18.48%), whereas antidepressants 105 (27.78%) was the major drug group prescribed by TCTH followed by anxiolytics 102(26.98%) and antipsychotics 37(9.79%). Tricyclic antidepressants(TCAs) were most frequently prescribed antidepressants followed by selective serotonin reuptake inhibitors(SSRIs) at TCTH whereas SSRIs were the major antidepressants prescribed by PPs. Anxiolytics and anticholinergics co-prescription with antidepressants and antipsychotics respectively, was a common observation among PPs and TCTH. Analysis of prescription revealed average number of drugs prescribed per prescription in teaching hospital is 2.16 vs 3.03 among the private practitioners. 18.25% Fixed drug combinations(FDCs) were prescribed by TCTH while 0% were prescribed by PPs. 55.39% and 55.56% drugs were prescribed from the NLEM-2013 by the PPs and the TCTH respectively. Conclusion: There were lesser number of drugs prescribed per prescription and more frequent use of drug combinations at TCTH while no drug combinations and greater number of drugs per prescription were prescribed by PPs. Newer class of drugs were more frequently prescribed by PPs. Key words: Drug utilization studies, antidepressants, antipsychotics, anxiolytics, Fixed drug combinations.

55-64

Authors: P B Dalvi, S S NANDAN, P R GANGURDE, S A GANGURDE

The aim of the current study was to design oral controlled release gastro-retentive drug delivery of Tinidazole. that are designed to retain in the stomach for a long time and have developed as a Local drug delivery system for better eradication of Helicobacter Pylori in peptic ulcer diseases. Tablets were prepared by direct compression and evaluated for evaluated for various physical parameters, Hardness, friability, drug Content, floating ability, Lag time, Swelling Index studies, and in vitro dissolution parameters as well as kinetics of release were assessed. Factorial design for 2 factors at 3 levels each was employed to systematically optimize drug release profile and Floating Behaviour. Sodium Alginate and Hydroxy Propyl Metheyl Celluiose (HPMC K15M) were taken as the independent variables. Response surface plots and contour plots were drawn.Compressed tablets exhibited zero order drug release kinetics, resulting in regulated and complete release until 12 hours. Polynomial mathematical models, generated for various response variables using multiple linear regression analysis, were found to be statistically significant (P < 0.05).Both the polymers had significant effect on the release profiles of the tablets, Besides unraveling the effect of the 2 factors on the various response variables, the study helped in finding the optimum Formulation ‘F4’ with Floating Lag Time (20 sec.) and having controlled release upto 12 hours (99.47%). Meanwhile, sustained profiles of drug release were also obtained. In general, these systems can float in the gastric conditions and control the drug release from the tablets.

69-72

Authors: Divya Stephy John

Introduction: Increase in research aptitude among students has resulted in a rise in the protocol numbers that get submitted to the Institutional Ethics Committee (IEC) for the purpose of recognition in dissertation, publications and forum presentations. Approval of research protocols by the IEC is considered the first barrier for most student researchers. Lack of solid concepts regarding dynamics involved in research seems to have resulted in unwarranted fear among students to pursue research. The current analysis attempts to identify areas of lacunae by retrospective reflection on the protocols submitted to the IEC in a teaching institution. Methodology: Retrospective Qualitative Analysis of 102 Protocols submitted by postgraduate medical students between January, 2013 to August, 2013 to the IEC were assessed by the following parameters: - Scientific and technical soundness of protocols, Ethical considerations and risk minimization strategies employed, Adequacy of documentation and scrutiny of Informed consent process, Temporal relationship between submission of protocols and commencement of the research procedures. Results: 79.41% of protocols were approved by the IEC. 95% of protocols were in proper format and adequate documentation.90% of the protocols were submitted for approval prior to the commencement of study. 20.59% of the submitted protocols were denied approval on the first hearing by the IEC. Discussion: We infer that majority of the postgraduate students are aware about the existence of guidelines in clinical research. The most common errors leading to non approval of research protocols are due to misjudgement regarding technical feasibility in available infrastructure, non comprehensive review of literature, non-addressal of ethical guidelines/risk minimisation strategies towards participants and inadequate documentation.

77-82

Authors: D Kapoor

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88-93

Authors: Jyoti Parkash, Kannubhai Rameshbhai Patel

Objective- Hepatoprotective activity of Chenopodium album leaves extract in CCl4 induced hepatotoxicity in rats. Method- The present study has been undertaken to evaluate hepatoprotective activity of Chenopodium album leaves extract in CCl4 induced hepatotoxicity in rats. The study was carried out by comparing SGOT, SGPT, Alkaline Phosphate, Direct Bilirubin, Total Bilirubin and Total proteins level in serum of different groups of rats. Histopathological study was also done on liver tissue of the all group of animals and compared with standard, positive control and negative control groups. Result- Rats treated with Chenopodium album leave extract caused a significant reduction in SGOT, SGPT, Alkaline phosphate, direct bilirubin, total bilirubin. Level of total proteins was found retrieving towards normalcy. Level of these enzymes was almost comparable to standard drug i.e. Silymarin. Hepatoprotective activity was confirmed by histopathological study of liver tissue of control and treated animals. Conclusion- From results it can be concluded that Chenopodium album possess hepatoprotective activity against CCl4­ induced liver toxicity in rats.

100-106

Authors: Pradeep Saha, Kanu Bhai Ramesh Bhai Patel

The hepatoprotective potential of Mahonia leschenaultii Takeda. (root wood and root bark) extract was evaluated in Country-Made Liquor (CML)-induced hepatotoxicity in Wister rats. The rats were made hepatotoxic by administering (CML) (3 ml/100g body weight/day in two divided doses) and corn oil (1 ml/100g body weight /day in a single dose) orally for 21 days. The administration of root wood and root bark of Mahonia leschenaultii Takeda. extract (200 mg/kg body weight) mixed with tween 80 (0.5% w/w) orally from day 15 to day 21 along with CML. The different biochemical parameters tested are ALAT, ASAT, ALP, LDH, TGL, total protein, total cholesterol, Albumin, total bilirubin and direct bilirubin. The results were compared with standard drugs i.e. Silymarin (70 mg/kg body weight) orally. The histopathological study was carried out and histopathological changes were observed and compared. The study showed that the extract of root wood and root bark of Mahonia leschenaultii Takeda. is definitely a hepatoprotective agent and help in reduction of liver damage. Key words: Hepatoprotective, Mahonia leschenaultii Takeda. Country-Made Liquor, Root wood, and Root bark

115-116

Authors: Mohammed Ather, P Padmavathi, D Padma Prabha, Mirza Mohammed Mohiuddin Baig, Dr Nasreen, Pallavi Gupta

Aim: To study the efficacy of Albendazole in treating Extra ocular and Orbital Myocysticercosis. Materials and Methods: This is a prospective interventional case study conducted at Department of Oculoplasty and Orbital disorder of Sarojini Devi Eye Hospital which is a tertiary care eye hospital. 6 cases of Myocysticercosis, 4 males and 2 females presented between Jan 2014 to June 2014 at department of Oculoplasty were included in the study. After clinical examination and radiological confirmation patients were given oral Albendazole 400mg bd for 3 weeks along with Tab.Prednisolone 1mg /Kg of body weight. They were evaluated clinically for control of symptoms like pain, redness and protrusion of eyeball and regression of signs like reduction in chemosis, Proptosis and tenderness. Results: All 6 cases responded to medical treatment by Albendazole and Prednisolone by total reduction in symptoms and signs thereby avoiding surgery on them. Conclusion: Ocular and Orbital Myocysticercosis respond well to medical treatment by Tab.Albendazole along with Tab. Prednisolone. Key Words: Myocysticercosis, Albendazole, Proptosis, Prednisolone.