ABSTRACT Analyse the prescribing pattern of antiepileptic drugs and evaluate the adverse drug reactions. The study was commenced with institutional ethical committee approval and patients were enrolled according to the study protocol after obtaining written informed consent. Prescriptions of all children with epilepsy were analysed. Adverse drug reactions were monitored by interviewing with parents, by physical examination and by necessary lab investigations in children. Causality assessment was done using WHO UMC (World Health Organisation and Uppsala Monitoring Centre) scoring system. Most of the epileptic patients were effectively managed with conventional AEDS. The highly used AED was sodium valproate. Clobazam was mainly used as adjuvant. Mono therapy was prescribed in 71% of patients. Multiple drug therapy was used in 29% patients. Phenytoin and Sodium Valproate contributed equally to the ADRs. Transient increase in liver enzymes, sedation and gastritis were the common adverse reactions and for all the ADRs, the causality assessment was “probable”. The treatment with AEDS was continued in all patients inspite of ADRs because the seizures were well controlled and the adverse effects did not significantly disrupt the normal activities. Since adverse drug reaction is the determining factor in drug selection due to similar efficacy of most antiepileptic drugs, our study gives an insight to promote rational drug use and reduce the adverse reactions by optimal drug selection, utilizing mono therapy and avoiding poly therapy whenever possible. Keywords:Epileptic children, Prescribing pattern, Antiepileptics, Adverse reactions.

ABSTRACT The safety and efficacy of triple combination of antiretroviral therapy for Human Immunodeficiency Virus-1 infection in Indian population are lacking. The current study was aimed to assess the immunological efficacy and safety of combination of 2 Nucleoside Reverse Transcriptase Inhibitor and 1 Non-nucleoside Reverse Transcriptase Inhibitors in Indian population. This was an open-label, non-randomized, multicentrestudy. The study comprised of fixed dose combination of Zidovudine 300 mg and Lamivudine 150 mg + Nevirapine 200 mg twice a day. Each subject was followed up for 24 weeks. The immunological efficacy was assessed by change in CD4 cells count and CD8 cells count from baseline. Safety was assessed by recording of adverse events, laboratory data, vital signs, clinical and physical examination. The paired t-test was used to analyze the data to measure the efficacy in terms of change from baseline to endpoint. A total of 100 subjects were enrolled. The statistically significant (<0.001) increase in CD4 and CD8 cells count was reported with mean increase from 212.39 cells/mm3 to 339.42 cell/mm3 and 758.50 cells/mm3 to 1058.40 cells/mm3, respectively. There was no new safety signal reported in the study. The combination of Zidovudine 300 mg and Lamivudine 150 mg + Nevirapine 200 mg proves the immunological efficacy and safety and tolerability and hence, promotes the use in the patients with HIV-1 infection of India. Keywords: Zidovudine, Lamivudine, Nevirapine, HIV-1 infection.

ABSTRACT Aceclofenac an analgesic and anti-inflammatory drug used in treatment of Osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Aceclofenac solid dispersions were prepared using hydrophillic polymers such as polyethylene glycol-4000, polyethylene glycol-6000 and Polyvinyl Pyrrolidone in the ratio of 9:1, 7:3 and 1:1 by solvent evaporation technique. The prepared formulations were evaluated for number of parameters like solubility, drug content uniformity, drug-polymer interactions, differential scanning calorimetry, X-ray diffractogram study showed the reduced number of peaks and decrease intensity of the peaks in the formulations, this suggests that the crystalline nature of the drug was converted to amorphous form, which is the reason for the higher solubility, faster dissolution rate and improved bioavailability of the drug when it is formulating in the form of solid dispersion. Drug Aceclofenac and its various formulations were subjected to scanning electron microscopy studies. The results showed the conversion of crystalline nature of the drug to amorphous form, which indicates enhanced solubility, dissolution rate and bioavailability of the drug. The in vitro release study was carried out on plain pure drug Aceclofenac and various solid dispersion formulations by employing pH 6.8 phosphate buffers as a dissolution medium. This shows an increased release of the drug from the dispersions in comparison to pure Aceclofenac drug. In vitro data of all formulations was subjected to first order plots, the graphs plotted were fairly linear and the ‘r’ values of all the formulations were very close to one, indicating the release mechanism followed first order kinetics. Keywords: Analgegic, Ankylosing spondylitis, Dispersion.

ABSTRACT Ocimum is an important aromatic herb of the Lamiaceae family. It is reported to associate with diverse phenolic compounds with strong antioxidant activity. The antioxidant effect is mainly due to phenolic components such as flavonoids, phenolicacids and phenolic diterpenes etc., The antioxidant activity of phenolics is mainly due to their redox properties, which allow them to act as reducing agents, hydrogen donors and singlet oxygen quenchers. Many studies demonstrated a possible relationship between phenolic content and antioxidant activity. In the present study, total phenolic content of Ocimum sanctum was estimated at varying pH and temperature conditions to know the stability of phenolics. The methanolic leaf extract of O.Sanctum showed a maximum phenolic content of 135mgGAE/gm extract at pH7.2 as againsta least phenolic content of 75mgGAE/gm extract at pH7.6. The phenolic content was also measured at various temperatures ranging from 10-520C and a maximum value of phenolic content was observed at 320C. With the above results it was concluded that pH and temperature have a considerable influence over the antioxidant activity of methanolic leaf extract of O.Sanctum plant. Keywords: Ocimum sanctum, Total phenolic content, Flavonoids, Antioxidant activity.

ABSTRACT Paracetamol, is a widely prescribed Non – steroidal anti inflammatory drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility, It needs enhancement in the dissolution rate in its formulation development. Binders such as Acacia and PVP K30 and use of superdisintegrant primojel and potato starch are tried for enhancing the dissolution rate of Paracetamol tablets. The objective of the present study is selection of best binder- disintegrant combination in order to enhance the dissolution rate of Paracetamol IR tablets by 22 factorial design. A total of four Paracetamol IR tablet formulations were prepared using selected combinations of the two factors as per 22 factorial design. Paracetamol tablets were prepared by wet granulation method and were evaluated for drug content, hardness, friability, disintegration time and dissolution rate characteristics. The dissolution rate (K1) values were analysed by ANOVA of factorial design. The individual and combined effects of binder and disintegrant on the dissolution rate (K1) of Paracetamol tablets are highly significant (P<0.01). Paracetamol tablets formulated employing superdisintegrant Potato starch at a level 15% of drug content and binder PVP K30 at 2% (Fa) disintegrated rapidly within 20 seconds and gave very rapid dissolution (92.05% in 30min) fulfilling the target dissolution of NLT 80% in 30min. Keywords: Paracetamol tablets, Factorial design, superdisintegrants (Primojel and potato starch).

ABSTRACT Amoebiasis is a major public health problem in developing countries. Drug toxicity must be acceptable to patients and should cause less harm than the disease itself. Assessment of hazard and risk varies throughout drug development as more persons are exposed for longer periods of time and more nonclinical information on the hazard is collected and evaluated. Cancer risk for human pharmaceuticals is important because drugs are taken at pharmacologically active doses and often on a chronic basis. Epidemiologic studies on patient populations have limited value because of the long latency period for most cancers and because these studies lack sensitivity. Besides the mutagenicity and genotoxicity testing of antiamoebic drugs as a part of pre-clinical trials, there are several literatures confirming the mutagenicity and genotoxicity of marketed antiamoebic drugs. Genetic abnormalities may also play a part in the incidence and severity of adverse reactions to drugs. In this paper a comprehensive review of literature pertaining to the mutagenic and genotoxic properties of some antiamoebic drugs are presented. Keywords: Mutagenecity, Genotoxicity, Amoebiasis, Antiamoebic, Metronidazole, Tinidazole, Chloroquine.

ABSTRACT QSAR analysis on a set of synthesized 4-Aryl-6-chloro-quinolin-2-ones and 5-Aryl-7-Chloro-1, 4-benzodiazepines analogues tested for growth inhibitory antiviral activity was performed by using MLR procedure. The activity contributions of these compounds were determined from regression equation and the validation procedures to analyze the predictive ability of QSAR models were described. The results are discussed on the basis of statistical data. High agreements between experimental and predicted antiviral activity inhibitory values are obtained. The results of this study indicate that the substitution of electron withdrawing group, aromatic ring , polarizability etc. parameters has significant effect on antiviral activity of this class of compounds thus simplifying design of new biological active molecule. Key Words: QSAR, MLR, Antiviral Activity

ABSTRACT The objective of the present work was to formulate pH triggered In-situ gel of Natamycincyclodextrin inclusion complex using carbopol 940, HPMC K4M and HPMC E50LV. Natamycin possesses activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium..pH triggered sol gels are shear thinning systems which show pH dependent gelation. Once instilled into the cul de sac of eye they rapidly get converted to gel increasing the precorneal contact time of drug with the corneal membrane. The prepared formulations were evaluated for various parameters such as clarity, pH, drug content, gelation capacity, gelling strength, viscosity, In-vitro release studies, pharmacokinetics studies, antimicrobial activity animal studies and short term stability studies. The FTIR results revealed the compatibility between the drug and polymers. Drug content was in the range 97.06% to 99.60 %. The pH was in range of 7-7.5. The viscosity of the formulations at 250±20C and 370±20C was in the range of 28-270cps and 49-306cps respectively. The optimised formulation NF8 was selected on the basis evaluation parameters. The In-vitro drug release revealed a sustained profile over a period of 6 hours and optimized formulation NF8 showing 38.39 % of release. The In-vitro antimicrobial study showed promising activity of NF8 against clinical isolates of candida albicansorganisms .Short term stability study indicated that 40±10C was appropriate storage condition for the formulations. Keywords: Natamycin, Carbopol 940, HPMC K4M, HPMC E50LV, pH triggered in-situ ophthalmic gel.