Clarification of the USP compendial procedure for phenoxybenzamine hydrochloride via updating impurity profiles.

The current United States Pharmacopeia-National Formulary (USP-NF) and the British Pharmacopoeia phenoxybenzamine (PBA) hydrochloride drug substance and drug product monographs describe an HPLC procedure for the determination of a specified impurity "tertiary amine phenoxybenzamine" and use the resolution of an "unknown related substance" from PBA as a system suitability criterion; however, neither structural information of the "unknown related substance" is provided nor reference standards of the two impurities are available. The ambiguity in pharmacopeias poses difficulties in implementing the procedure for quality control. To clarify the degradation pathways, and incorporate the impurity profile of PBA into the USP monographs, the degradation of PBA was revisited. PBA undergoes rapid degradation in neutral or basic aqueous solutions to generate the "tertiary amine phenoxybenzamine" as the predominant degradation product, which was confirmed as phenoxybenzamine hydroxide (PBA-OH). In addition, the "unknown related substance" was proposed as the phenoxybenzamine nitrile (PBA-CN) on the basis of LC-MS studies. The identity of PBA-CN was unambiguously verified via chemical synthesis, HPLC and NMR analyses. A stability-indicating method was developed and validated for the determination of PBA and its impurities, and was used to support USP monograph modernization.

Quality of Life in Head and Neck Cancer Patients.

To assess the quality of life in head and neck cancer patients and the various factors which affect the quality of life in head and neck cancer patients was the main aim of the study. A prospective longitudinal study with a sample size of 130 patients was done within the time period of one and a half years. Patients with biopsy proven squamous cell carcinoma of the head and neck were treated as per their treatment protocol either by combined modality or single modality. Follow up at the completion of treatment was done and the quality of life questionnaire was filled out. QoL was assessed pre-treatment and at 4 times at different stages of follow up period. Demographic data was also taken into consideration for comparison which showed that head and neck cancer is more common in the males (80%) between the age group of 35-50 years, chronic tobacco chewers (45%) with most common site of cancer being the oral cavity (61%). Majority of the patients presented at Stage IV of their disease (35%) with largest HRQoL changes seen within the first three months after commencement of treatment. The most debilitating modality of treatment was Surgery + CTRT. Detailed assessment of the various factors which hamper the QoL in head and neck cancer patients should be done by which we can provide quality care and a completely new view into the health care experience and improving patient satisfaction.

Comparison of Modified Cartilage Shield Tympanoplasty with Tympanoplasty Using Temporalis Fascia Only: Retrospective Analysis of 142 Cases.

The current study compares outcomes of modified cartilage shield tympanoplasty (CST) with temporalis fascia tympanoplasty in type I procedures in Indian patients. Graft uptake rates are better with the CST technique and hearing results are almost equivalent with both techniques except at 8000 Hz where improvement in hearing was found better with the use of temporalis fascia alone. The CST technique used in the study is unique.