Informatics Publishing Limited

J.S. Pawar ¹, A. B. Roge ¹, S. M. Vadvalkar ¹

Affiliations
1 Nanded Pharmacy College, Opp-Kasturba Matru Seva Kendra, Shyam Nagar, Nanded -431605 Maharashtra, IN

Abstract

Transdermal drug delivery system is emerging system as compared to oral and parenteral. In TDDS, patch system was developed to control the release of drug. Conventional transdermal drug delivery system achieved advantages over the oral and parenteral. Consequently a number of vesicular drug delivery systems such as liposomes, niosomes were been developed as novel transdermal drug delivery system. Firstly, it delivers the drug at a rate directed by the needs of the body, over the period of treatment. Secondly, it channels the active entity to the site of action. Liposomal as well as niosomal systems, are not suitable for transdermal delivery, because of their poor skin permeability, breaking of vesicles, leakage of drug, aggregation, and fusion of vesicles. To overcome these problems, a new type of carrier system called "transfersome", has recently been introduced, which is capable of transdermal delivery of low as well as high molecular weight drugs.Transferosome is a supramolecular entity that can pass through a permeability barrier and there by transport material from the application to the destination site. These are more elastic than standard liposomes. Transferosome has been widely used as a novel carrier for effective transdermal drug delivery. Transferosome enhances the penetration of most of the low as well as high molecular weight drugs, while in case of lipophilic drugs the entrapment efficiency can reach upto 90%. it is now widely used as a novel carrier for both systemic as well as topical delivery of drugs.

Keywords

TDDS, CTDDS, NTDDS, Transfersome,Liposome

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A. B. Roge ¹, G. R. Shendarkar ¹, N. Y. Gond ¹, N. B. Ghiware ¹, S. M. Vadvalkar ¹

Affiliations
1 Nanded Pharmacy College, Opp- Kasturba Matru Seva kendra, Shyam Nagar, Nanded -431605, Maharashtra, IN

Abstract

No one UV Spectrophotometric method is available for simultaneous estimation of Risperidone (RIS) and Trihexyphenidyl HCL (THP). The objective of present work is to develop a new, simple, accurate and sensitive UVspectrophotometric two wavelength method for simultaneous determination of RIS and THP in combined pharmaceutical dosage form. Two wavelength i,e 238 nm and 271 nm were selected for estimation of RIS where as wavelength 217 nm was selected for estimation of THP using 0.1 N HCL solution as solvent . RIS and THP shows linearity in the concentration range of 0-40 μg/ml and 0-80 μg/ml respectively. The method was validated statistically.

Keywords

Risperidone, Trihexyphenidyl HCL, Two wavelength method

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S. B. Gaikwad ¹, R. L. Bakal ¹, A. V. Chandewar ¹, A. B. Roge ¹, R. S. Sakhare ¹, S. G. Shep ¹

Affiliations
1 P. Wadhwani College of Pharmacy, Yavatmal - 445001, IN

Abstract

Ursodeoxycholic acid is a dihydroxy bile acid with a rapidly expanding spectrum of usage in acute and chronic liver diseases. The various mechanisms of action of this hydrophilic bile acid include direct cytoprotection, detergent action on dysfunctional microtubules, immunomodulation and induction of hypercholeresis.

 

Its efficacy in primary biliary cirrhosis and primary sclerosing cholangitis as an adjunct to medical therapy has been well established. Newer indications include its use in the management of chronic hepatitis, cirrhosis, post liver transplant rejection, graft versus-host disease and acute viral hepatitis, where it not only relieves symptoms of holestasis but also arrests ongoing hepatocyte necrosis.

Keywords

Biliary Cirrhosis, Primary Sclerosing Cholangitis, Ursodeoxycholic Acid.

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R. S. Sakhare ¹, A. B. Roge ¹, R. L. Bakal ¹, A. D. Dewani ¹, M. D. Kshirsagar ¹, A. V. Chandewar ¹

Affiliations
1 P. Wadhwani College of Pharmacy, Yavatmal-445001 (M.S.), IN

Abstract

A simple, precise, accurate, rapid and reproducible reverse phase high performance liquid chromatographic procedure was developed for simultaneous determination of Drotaverine HCL and Mefenamic Acid in tablet dosage form at a single wavelength. The mobile phase used was a combination of Methanol:Acetonitrile:KH₂PO₄ Buffer (10 mM):(40:40:20) pH 3.5. The detection of the combined dosage form was carried out at 240 nm and flow rate was set to 1ml/min. Linearity was obtained in the concentration range of 3 to 30 μg/ml of Drotaverine HCL and 6 to 33 μg/ml of Mefenamic Acid with correlation coefficients of 0.9998 and 0.9999, respectively. The results of the analysis were validated statistically and recovery studies confirmed the accuracy of the proposed method.

Keywords

Drotaverine HCL, Mefenamic Acid, RP-HPLC, Simultaneous Estimation.

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A. B. Roge ¹, P. S. Tarte ¹, M. M. Kumare ¹, G. R. Shendarkar ², S. M. Vadvalkar ²

Affiliations
1 CRPS, Nanded Pharmacy College, Nanded, IN
2 Nanded Pharmacy College, Nanded, IN

Abstract

Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. The objective of the review article is to furnish comprehensive portrayal of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article recapitulates the collective views of industry practices on the topic of forced degradation studies. This article reiterates a practical interpretation and summary of the available guidance and some suggestions for best practices for conducting forced degradation studies.

Keywords

Active Pharmaceutical Ingredient (API), Drug Product (DP), Forced Degradation, ICH, FDA Guidance, Validation, Method Development.

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