ABSTRACT
Objectives: To document the dose received by brachial plexus (BP) in patients treated with intensity-modulated radiotherapy (IMRT) for head-and-neck squamous cell carcinoma (HNSCC) and report the incidence of brachial plexopathy. Methods: Newly diagnosed patients of HNSCC treated with radical or adjuvant IMRT were included in this retrospective study. No dosimetric constraints were applied for BP maximum dose equivalent dose (EQD2 α/β = 3). Patients with minimum 6-month follow-up were included and patients with suspicion of plexopathy were evaluated further. Results: Sixty-seven patients were eligible and 127 BP were analyzed. The mean BP maximum dose (BPmax) was 62.4 Gy (+6.9), while mean BP volume was 28.1 cc (+4.1). Proportion of patients receiving BPmax >66 and >70 Gy were 34.7% and 14.2%. The mean BPmax for T4 tumors was significantly higher than T1 tumors (65 vs. 57.5 Gy, P = 0.005) but when adjusted for N-category, T-category was not independently significant in accounting for BPmax >66 or >70 Gy. Mean BPmax for N0 versus N2+ was 59.8 versus 65.6 Gy (P = 0.0001) and N1 versus N2+ was 61.6 versus 65.6 Gy (P = 0.018). After adjusting for T-category, patients with N2+ had a mean 4.2 Gy higher BPmax than N0-N1 (P = 0.0001). Stage III–IV patients had a mean six Gy higher BPmax doses than Stage I–II disease (P = 0.0001). With a median follow-up of 28 months (interquartile range 16–42), no patient had brachial plexopathy. Conclusion: Clinically significant plexopathy was not seen in spite of majority having over 2-years follow-up and a third of patients having dose above the recommended tolerance. Only nodal category independently influenced dose to the brachial plexii
ABSTRACT
The present investigation was undertaken with an objective of formulating modified release (MR) matrix tablets of Oxcarbazepine (OXC) an anti-epileptic drug, based on cellulose ether polymers like Hydroxy Propyl Methyl Cellulose (HPMC K4M and LVCR 100) and Hydroxy Propyl Cellulose (HPC JF) as drug release retardants to overcome poor patient compliance and exposure to high doses associated with currently marketed immediate release (IR) dosage forms. The tablets were prepared by direct compression process and evaluated for various physico- chemical/mechanical parameters. Among three polymers used, HPMC LVCR 100 is selected as release retardant based on the viscosity and gel formation during dissolution. The effect of different fillers like Avicel PH 101, Avicel PH 105, Pre gelatinized starch (PGS), maize starch with spray dried lactose (FLOWLAC) and Di-calcium phosphate (DCP) on OXC release was also studied and the OXC percent release at the end of 12h is in the order of DCP>FLOWLAC>Avicel PH 101>Avicel PH 105>PGS. Based on the dissolution data obtained with different fillers and keeping in view of the results from the pre compression studies, and gel layer retaining with the matrix tablets, Avicel PH 105 was selected as carrier to carry out further formulation development. Since, OXC is poorly water soluble drug, solubilizing agents like surfactants, cyclodextrins and polyethylene glycols were included in the formulations and their effect on OXC release was studied in order to achieve therapeutic effective levels. Formulations containing 20% (w/w) of Hydroxy Propyl-β-Cyclodextrin gave superior OXC release of 85.50 ± 1.62% at the end of 12hours and fulfils the regulatory requirement. The dissolution data was also evaluated for drug release kinetics and mechanisms.
ABSTRACT
A case of pseudohypertension as demonstrated by a very high systolic blood pressure (more than 280 mm of Hg) by sphygmomanometry and low blood pressure (148/30 mm of Hg) as evidenced by intra-arterial recording who also had severe calcific aortic stenosis, calcified right brachial artery and angina pectoris is described. This case is reported because of the unusual combination of lesions and the therapeutic challenge it poses.