Posted by admin on Sep 1, 2012 in |
Aim: To check the effectiveness of 0.15% Benzydamine hydrochloride on oral mucositis secondary to cancer chemotherapy Methods: In the past few years, multiple cases were referred to our department for the management of oral manifestations of cancer chemotherapy for various malignancies. Out of these patients, we selected 5 patients and used a simple, inexpensive treatment modality in consideration with patient’s affordability and convenience. They were prescribed 0.15% Benzydamine hydrochloride oral rinse (Tantum) for the relief of oral discomfort. Results: Significant reduction in oral mucositis and discomfort was observed after a week. The treatment was continued for 3 weeks till complete disappearance of oral ulcers. Conclusion: Benzydamine oral rinse is simple, effective, safe, inexpensive and well tolerated therapeutic modality for prophylactic and palliative treatment of chemotherapy-induced oral mucositis. It holds a special significance in the developing countries such as India for the lower socioeconomic...
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Posted by admin on Sep 1, 2012 in |
The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF) proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a...
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Posted by admin on Sep 1, 2012 in |
Tinospora cordifolia is known for a wide range of medicinal properties. In this study, cardiovascular and antimicrobial properties of aqueous and ethanolic extracts of Tinospora cordifolia were evaluated. Dose dependent negative ionotropic and chronotropic effects were observed with both aqueous and ethanolic extracts. The effects were antagonized by atropine indicating involvement of muscarinic receptors. Maximum antimicrobial activity was found with ethanolic extract of Tinospora cordifolia (15mm) against Pseudomonas aeruginosa. The organism showed resistance to aqueous extract giving an inhibition zone of 0.3mm. The data suggest that Tinospora cordifolia could be of benefit in arrhythmias and microbial infections....
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Posted by admin on Sep 1, 2012 in |
Tridax procumbens L. is a well known medicinal plant. In the present study alkaloids from pedicle and buds of the plant were extracted and evaluated for antimicrobial activity by ‘Disc Diffusion Assay’ against selected bacteria (Escherichia coli, Staphylococcus aureus and Proteus mirabilis) and fungi (Aspergillus flavus, Aspergillus niger, Candida albicans and Trichophyton mentagrophytes). Minimum inhibitory concentration, minimum bactericidal/fungicidal concentration and total activity of each active extract were also evaluated. Significant antibacterial activity was recorded by alkaloids of pedicle against P. mirabilis (IZ 20mm, AI 0.83 and same MIC, MBC 0.039 mg/ml) and antifungal activity was recorded by buds against C. albicans (IZ 9.2mm, AI 0.92, MIC 0.625 mg/ml and MFC 1.25 mg/ml). MIC ranged from 0.039 mg/ml-0.625 mg/ml and MBC/MFC ranged from 0.039 mg/ml-1.25 mg/ml against susceptible pathogens. It is noteworthy that MIC values of active extracts was found very low (0.039 mg/ml-0.625 mg/ml) and was recorded below 1 mg/ml against inhibited pathogens, thus ascertain their strong antimicrobial potential against selected microbes. Thus, the result of the present study...
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Posted by admin on Sep 1, 2012 in |
Validation is an integral part of quality assurance; the product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Recently validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization, facilities and processes involved in pharmaceutical manufacturing process impact significantly on the quality of the products. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate...
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