Karnataka

The purpose of this research was to develop a desired topical formulation containing clotrimazole for treatment of fungal infections like eczema, itching, pruritis etc. Topical formulation enriched with SLN of clotrimazole were prepared. The solid lipid nanoparticulate dispersion of clotrimazole was prepared by hot homogenization technique using polymers like Carbopol 934, mannitol and PEG 6000. The nanoparticulate dispersion was evaluated for various parameters such as physical evaluations, particle size, diffusion studies, DSC, SEM, stability studies. The solid lipid nanoparticulate dispersion showed mean particle size less than 1000 nm. Differential scanning Calorimetry studies revealed no drug excipient incompatibility. Diffusion studies release profile of clotrimazole from nanoparticulate dispersion showed prolonged drug release. And all other evaluations were found to be complied the limits. Thus it can be concluded that formulation of SLN containing clotrimazole can be successfully formulated to localize the drug in the skin for to treat topical fungal infections.

The aim of the study is to assess the usage of alteplase in stroke patients which is second leading cause in worldwide. Its beneficial effect in stroke patients is to disperse the thrombus within an occluded cerebral vessel and to limit ischemic damage within surrounding tissue (ischemic penumbra) and is safety and efficacy towards the stroke patient. This is prospective observational study, which assed the current usage of tissue Plasminogen activator (tPA) alteplase in stroke patients. This study was conducted in Stroke patients in Adichunchanagiri Hospital and Research Center. Duration of our study is sixteen months. A total of 140 stroke patients were assigned to receive alteplase. In which 102 (72.85%) Patients were treated before 3 hours (Window period) the study population were elderly with the age between 53-57 were 40.70% (n=48), and followed by 63-67 were 22.03 % (n=26), where as in female elderly patients the age group between 48-52 were 59.10% (n=13) and followed by 53-57 were 18.18 (n=4), elderly patients are more prone to have stroke. Therefore 54.23% (n=64) were recoverd in the post intervention benefit of alteplase in stroke patients,as in female patients were 68.18% (n=15) and age between 78-82 years only one patient died during the treatment. This study shows that efficacy and safety of thrombolytic in stroke patients within 3 hours and recover of the patients from the stroke is high rate. The findings encourages wider use of thrombolytic therapy for suitable patients treated in stroke centres can be a beneficial in future endeavours.

The present study deals with the elaborated overview of comparative study of in-process and finished product quality control tests for parenteral products taking compendia specifications of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) into consideration. When it comes to most sensitive parts of body i.e.; veins, a high degree of precautions should be taken during and after production of product for it to avoid any hitches. The sterility of these parenteral products, as well as accuracy in the calculation and preparation of doses is of great importance and a must in terms of compliance. The high graded quality product always refers to a product which is within the compendia limits. This article focuses on the comparison of Pharmacopoeial specifications of parenteral preparations, the procedures that are employed to maintain the quality and sterility of these ophthalmic products. This covers specifications and limits of different dosage forms according to different Pharmacopeia (like IP, BP, USP, JP etc.) which helps in comparative study of specifications provided in different Pharmacopeia as well as highlighting the differences in standards and also focussing on the specifications of different nations. Different regulatory requirements of the respective countries demand products with different specific limits so this comparative study will help in meeting all the requirements of all the pharmacopoeias and later the regulatory requirements of that particular country.

An orphan drug is a pharmaceutical agent that is used to treat a rare medical condition (viz., Huntington’s disease, myoclonus disease, Tourette syndrome etc.). They receive little attention from pharmaceutical companies as the small patient population could not justify the huge investment required for drug development. In the last 20 years, orphan drug act has been adopted in several countries around the world (USA, Japan, Australia, and the EU) and has successfully promoted R&D investments to develop new pharmaceutical products for the treatment of rare diseases, but it faces future challenges like returns on the huge R & D costs, funding sources and initiatives for development of orphan drugs.

  ODTS are solid unit dosage form which dissolve or disintegrate rapidly in mouth without water. So, acceptability of this dosage form mainly depends on its taste i.e. mouth feel. So it becomes necessary to develop such an ODT for that must be acceptable in taste to patient many techniques are available to mask the taste of drugs. These techniques not only serve as to mask the taste of drug but also to enhance the bioavailability of drug. Taste masking technology involves the development of a system that prevents the active substance interacting with the taste buds, thereby eliminating or reducing the bitter taste. This review describes the commonly used techniques that are adopted for masking the taste of bitter drugs and dosage form palatable. The common methods include addition of sweeteners, coating of drugs adjusting the pH values, granulation, freeze drying, forming complex with ion exchange resins etc. Key words: orodispersible tablets (ODTs), taste masking.  

Many oral dosage forms, bulking agents and beverage products have unpleasant taste. The bitter taste is an undesirable trait of the product or formulations and can considerably affects its acceptability by consumer. So, they should be formulated in a palatable form. Bitter taste in such systems can be reduced or eliminated by various methods, but no universally applicable technologies are yet recognized. This article is about the discussion of recent approaches for minimizing the unpleasant taste for oral pharmaceuticals.   Key words: Taste masking, Eudragit.

The concept of controlled release tablet can be utilized to provide a long lasting and more reliable release of drug in GIT to ultimately develop a once daily formulation. Thus, they prolong the dosing intervals, but also increase patient compliance beyond the level of existing conventional dosage forms. Erythromycin, macrolide antibiotics is used in the treatment of Mycoplasma pneumoniae infections, Chlamydial infections, etc. It is a drug with short biological half-life 1.5 hrs and dosing frequency more than one per day which makes it an ideal candidate for controlled release. The present investigation was planned to formulate the Erythromycin stearate once daily controlled release tablets. The tablets were prepared by direct compression method and were subjected for in vitro drug release studies. The mechanism of drug release was determined using various kinetic models. The results revealed that all the formulated tablets had acceptable physical properties and showed release up to 24 hrs. The kinetic studies revealed that all the formulations followed Zero order release kinetics. The tablets were prepared by Direct Compression technique and evaluated for various parameters. The optimized formulation contains Erythromycin Stearate as active ingredient, HPMC K15M, Chitosan and Xanthan gum as rate retarding polymers.

The present study was carried out to monitor, estimate the prevalence and consequences of ADRs on treatment of TB and to assess causality, predictability, preventability and severity of the ADRs. A prospective observational and active surveillance study was conducted over a period of 9 months. Each reported ADR was assessed for its causality, severity, predictability and preventability as per standard algorithms. The management and outcome of ADRs were determined. A total of 128 ADRs (in 53 patients) were identified out of which the prevalence of ADRs in female was found to be 31.58% and 29.66% in male patients. The causality assessment by Naranjo’s scale showed that out of 128 ADR’s, 128 (100%) ADR’s were probable and based on WHO probability assessment scale 119(92.97%) were possible where as 9(7.03%) were probable. Preventability assessment showed that 125 (97.66%) were not preventable and 03 (2.34%) were definitely preventable. Severity Assessment by Modified Hartwig and Siegel Scale showed that 82 (64.06%) ADRs were mild and 46(35.94%) ADRs were moderate. 128(100%) were found to be predictable. Majority of the ADRs were recovered without giving symptomatic treatment. The study concluded that there is a need of a system for proper monitoring of ADRs caused by anti-TB drugs in RNTCP centre.  The counselling of patients for timely prevention, detection and management of ADRs will helps in further ADR occurrence minimisation.

Conventional drug therapy requires periodic doses of therapeutic agents. These agents are formulated to produce maximum stability, activity and bioavailability.  Floating drug delivery systems (FDDS) have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting gastric emptying rate for a prolonged period of time. While the system is floating on the gastric contents drug is released slowly at the desired rate from the system. The present study mainly focuses on the development and evaluation effervescent based floating matrix tablet of famotidine. This oral drug delivery offers several advantages over the standard conventional oral dosage forms. Effervescent based floating matrix tablet of famotidine was prepared using sodium bicarbonate as effervescent agent and by incorporating hydrophobic agent stearic acid which retards the drug release and allow the dosage form to float on gastric fluid for several hrs. Then the tablet was evaluated for hardness, friability, drug content and in vitro drug release. On the basis of the preliminary trials, a 32 full factorial design was employed to study the effect of independent variables, HPMC K4M: Carbopol 934P ratio (X1) and concentration of effervescent agent (X2) on dependent variables like floating lag time, Q4 and Q8. The best batch (F3) exhibited optimum floating lag time (16 sec), drug content (98.94%), Q4 (54.36 %), Q8 (93.98%) and similarity factor (83.92). The controlled release of famotidine was observed and good fit to the zero order was demonstrated.

Oxidative stress caused by free radicals is implicated in the pathogenesis of many diseases.  In order to continue the other plants with potential benefits with free radical scavenging properties, researchers start looking forward for exploring new plants with rich in flavonoids and polyphenolics. These constituents possess not only free radical scavenging properties but also they are highly safe in the treatment of many diseases/disorders. In one of the field survey, it was identified that Sesbania grandiflora(Linn) was extensively used by folklore practitioner for treating many human ailments such as flatulent-colic, astringent, cooling, bitter, tonic, anthelmintic, febrifuge, dyspepsia, diarrhea and gastralgia, pain, nyctalopia, anaemia, emaciation. Even the plant is a rich source of antioxidants such as phenolics and flavonoids. However, scientific information about the plant and concentration of these constituents was not updated. Hence it was planned to undertake the plant of the present study for its spectrophotometric determination of total phenolic and flavonoid contents from 70% alcoholic extract of flowers of Sesbania grandiflora using Catechol and Quercetin as reference standard. It was observed that, 70% alcoholic extract of flowers of Sesbania grandiflora(Linn) showed 64.0mg/G of total phenol equivalent to catechol and 28.80mg/G of flavonoidal content equivalent to quarcetin standard.  Hence it may be concluded that the plant many be potential source of antioxidant principles such as phenolic and flavonoid. Furthermore, the plants possessing these antioxidants can be highly beneficial for the treatment of many common human ailments. Key-Words: Catechol, Flavonoid, Phenolic, Quercetin, Sesbania grandiflora(Linn).