1. | DDESIGN AND INVITRO EVALUATION OF SUSTAINED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE BY DRY GRANULATION METHOD |
| Mathew George*, Lincy Joseph, Sanjay Kumar Shivade, Anjana MN |
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The main objective of the experimental work under taken was to develop and in vitro evalution of Diltiazem hydrochloride sustained release dosage form by optimization of the developed formulation. Diltiazem hydrochloride can be increased in duration for long time in the body by formulating it in a sustained release dosage form using optimum amount of hypromellose, hydroxypropyl cellulose and methacrylic acid copolymer and tablets were prepared by dry granulation method, optimized on the basis of acceptable tablet properties and in vitro release..In this research work identification of pure drug, data analysis, pre compression parameters formulation, composition of formulations and post compression evaluation were discussed. The following assumptions have been made in developing these designs, drug disposition can be described by one compartment open model, absorption is first order and complete, the rate of release of the drug from maintenance dose should be zero, the release of drug from loading dose should follow first order kinetics. The granules prepared by melt granulation technique evaluated for characterization such as bulk density, tapped density, hausners ratio, angle of repose, cars index all granules shows good flow property. The tablet of Diltiazem HCL evaluated for characterization such as hardness, friability, weight variation and content uniformity all tablets shows sufficient hardness and friability shows that tablets are having sufficient strength. All results were satisfactory. The in vitro drug release studies for the prepared formulation were conducted for a period of 15 hr using an tablet dissolution tester (USP XXIII) Type - II apparatus (rotating paddle) set at 100 rpm and a temperature of 37 ± 0.5°C formulation was placed in the 900 ml of the medium. The results of dissolution studies indicated that formulation F5 was found to be most successful as it exhibits drug release pattern very close to theoretical release profile.Key Words:- Diltiazem hydrochloride, Sustained release, Methacrylic acid copolymer, Hypromellose, Roller compactor.
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2. | IN VITRO AND IN VIVO INVESTIGATION OF TOPICAL FORMULATIONS OF ERYTHROMYCIN |
| Kripa Sagar Yadav* |
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The interest in in vivo/in vitro correlations in the dermal field of research has increased steadily. This study was designed to demonstrate the rate of release of Erythromycin from two different, marketed topical cream formulations; by performing In vitro and in vivo experiments. For In Vitro study the penetration of Erythromycin from two different formulations was evaluated using human cadaver skin in a Franz Diffusion cell setup. The release rate of Erythromycin from two different formulations in the receptor phase through human cadaver skin was monitored chromatographically. Whereas in In Vivo experiment the pharmacokinetic study of two marketed formulations of Erythromycin was performed by Dermatopharmacokinetic method using 12 healthy Indian male subjects. Pharmacokinetic parameters of Erythromycin were calculated as Cmax, Tmax, AUC (0-t) and AUC (0-∞). Erythromycin was estimated in Stratum Corneum using a validated chromatographic method. Different release profiles of Erythromycin were observed in both the formulations for both the studies. In conclusion, the linear In Vitro – In Vivo correlation for the release rate of Erythromycin was observed for both the two Formulations. But the In Vitro experiments using the cadaver skin is more time consuming than the In Vivo Dermatopharmacokinetic absorption experiments.Key Words:- Erythromycin, Dermatopharmacokinetic, Franz diffusion cell, Human cadaver skin.
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3. | PHARMACEUTICAL PREFORMULATION FOR PRODUCT DEVELOPMENT & ANALYTICAL TECHNIQUES USE IN NEW DOSAGE FORM |
| Md. Mehdi Hasan*, Sabbir Al Habib,Mumu Mishouri Islam, Md. Mohshin Islam, Md. Salimul Karim, Kallol Banik, Harun Ar Rashid |
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Fundamentals to preformulation studies are analytical techniques. Evaluation of the quality of materials, precursors of products or final product is not possible without them. Measuring pharmacological and biological response in the clinical and preclinical stages are also not possible without them. Analytical techniques should be selected based on several categories such as specificity, accuracy, precision, sensitivity, and speed of a test must be verified for selection of the method. Several analytical techniques like Spectroscopic, Chromatographic, Thermal methods and some specific detection methods like Capillary electrophoresis are very convenient method for generating preformulation data. The intrinsic chemical data and physical properties of every drug are distinctively considered before development of pharmaceutical formulation. This property of drug act as the basic structure that is responsible for the binding of drug with other pharmaceutical ingredients. Several research scientist carries out these preformulation studies and they are again reviewed later. When a preformulation study is executed on a newly synthesized compounds or extracted compound, several crucial information such as the degradation process, any adverse conditions relevant to the drug, bioavailability, pharmacokinetics and formulation of similar compound and toxicity can be obtained. Preformulation studies strengthen the scientific foundation of the steerage, give restrictive relief and conserve resources within the drug development and analysis method, improve public safety standards, enhance product quality within the fabrication of indefinite quantity type. Objective of preformulation study is to develop the exquisite, stable, effective and safe indefinite quantity kind by establishing kinetic rate profile, compatibility with the opposite ingredients and establish physicochemical parameter of new drug substances. Polymorphic substances who have both amorphous and crystal forms shows totally different chemical, physical and therapeutic description of the drug molecule. The main purpose of this review article focuses on the various preformulation factors which distinctly impacts the development of new dosage form like drug solubility, partition coefficient, dissolution rate, polymorphic forms and stability. The present article is framed with the target to produce an in-depth insight the appliance of Analytical Techniques in Preformulation Study.Key Words:- Preformulation Study, Thermal Methods, Dosage Forms, Quality Control, Solubility analysis, Compressibility.
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4. | A CONCISE REVIEW ON THERAPEUTIC POTENTIAL OF AMLA (EMBLICA OFFICINALIS GAERTN.) |
| Amit Vaibhav*, Meera Antiwal, Jai Prakash Singh & Om Prakash Singh |
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Indian gooseberry or Amla or Emblica officinalis Gaertn. or Phyllanthus emblica Linn, one of the most important medicinal plant in the Ayurveda which is the world’s most ancient traditional medicine system. Various parts of this plant are used in different diseases, but the most important and potent part is the fruit which contains majority of active constituent. Amla or Emblica officinalis is used either alone or in combination with other plants to treat several ailments like cancers, chronic inflammotary diseases like hypertension, high Cholesterol, Diabetes, influenza, Chronic cough, cold, Chronic infections, Chronic fatigue, liver problems, heart disease, ulcer, anemia and various other diseases. The major properties of Amla are Anti-inflammatory, Antioxidant, free radical scavenging , Antidepressant, Antifungal, Anti-diabetic, hypoglycemic, Anti ulcerogenic, Antimutagenic, Anti-cancer,anti-proliferative, Cytotoxic effects, Insecticidal, Larvicidal, mosquitocidal , Immunomodulatory, Hepato-protective, Radioprotective, Hypolipidemic and several other activities as demonstrated in numerous preclinical studies. This review summarizes the results related to these properties and also emphasizes the aspects that warrant future research establishing its activity and utility in different disease conditions specially in humans.Key Words:-Amla, Emblica officinalis, Ayurveda, Active constituent, Preclinical studies.
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5. | ANTISTEROIDOGENIC EFFECT OF AZADIRCHTA INDICA TINCTURE (AIT) AND AZADIRCHTA INDICA 30 POTENCY (AI 30) IN MATURE FEMALE RATS |
| G.Nirmal* and Arun Bhasme |
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The present work is to find the Azadirchta indica tincture (AIT) and Azadirchta indica 30 potency (AI 30) could be recommended for used as female contraceptives. The parameter chosen for the present investigation is ovarian activity in sexually mature female rats after treatment with the Azadirchta indica tincture (AIT) and Azadirchta indica 30 potency (AI 30). For this, arrest in the oestrus cycle, changes in the weighs of ovaries, biochemical estimation of ascorbic acid, total cholesterol, inhibition of the activity of enzymes, G-6-PD and Δ5-3β-HSD that are responsible for the synthesis of steroidal hormones in the ovarian tissue, have been taken as the experimental parameters. From the overall results, it is evident that oral administration of the AIT & AI 30 causes inhibition of both steroidogenic enzymes and elevation of ovarian cholesterol and ascorbic acid content and induces functional sterility without toxic symptoms and they exert antisteroidogenic/antifertility activity in rats.Key Words:-
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