Ahmad A.,Jina Pharmaceuticals Inc. |
Sheikh S.,Jina Pharmaceuticals Inc. |
Taran R.,CHL Apollo Hospital |
Srivastav S.P.,Lions Cancer Detection Center |
And 8 more authors.
Clinical Breast Cancer | Year: 2014
Background Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel (Taxotere) drug for treatment of cancer patients. NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m2 in metastatic breast cancer patients. Patients and Methods A total of 72 patients were randomized in a ratio of 2:1 (NDLS:Taxotere). Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere. Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle 6. Results Overall therapeutic response (complete + partial) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5% and 26.3%, respectively, indicating better response in patients treated with NDLS. Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere. Conclusion NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients. © 2014 Elsevier Inc. All rights reserved.
Mahajan N.,Maharashtra Institute of Pharmacy |
Sakarkar D.,Maharashtra Institute of Pharmacy |
Manmode A.,Astron Research Ltd |
Pathak V.,Post Graduate Institute of Veterinary and Animal science |
And 2 more authors.
Advanced Science Letters | Year: 2011
Nanoparticles (NPs) are proposed for targeted drug delivery to the inflammation site in severe cases of inflammatory bowel disease (IBD) where state-of-the-art delivery devices fail. Meselamine (5-Aminosalicylic acid), entrapped into nanoparticles was administered either orally or rectally to male Wistar rats suffering from a preexisting experimental colitis induced by acetic acid. Meselamine, a front line drug in the treatment of ulcerative colitis, was incorporated within poly(lactic-co-glycolic acid) i.e., PLGA nanoparticles, which were administered once a day orally and rectally for five consecutive days. Clinical activity score, colon/body weight ratio, ulcer index and myeloperoxidase activity were determined to assess the inflammation. All nanoparticulate formulations proved to be efficient as compared to the free drug in suspension in mitigating the experimental colitis. The clinical activity score, myeloperoxidase activity and ulcer index decreased significantly (p<0.05*), after the oral administration of meselamine nanoparticles suspension. The free drug, meselamine, suspension does not found effective in terms of clinical activity, myeloperoxidase activity and ulcer index, as is evident from the nonsignificant decrease in clinical parameters. The meselamine nanoparticles proved their potential to retain the drug from systemic absorption as evident by a significantly reduced clinical activity, myeloperoxidase activity and ulcer index. The nanoparticles potential in reducing the inflammation was further proved by the histopathology of the resected colon from every group of animals. The use of drug loaded nanoparticles offers several advantages compared to standard therapeutic strategies such as a higher selectivity in adhesion to and enhanced drug penetration into the inflamed tissue. © 2011 American Scientific Publishers.
ASTRON RESEARCH Ltd | Date: 2014-03-25
The present invention relates to a stable pharmaceutical composition of Tigecycline and process for the preparation of the same. The composition comprises Tigecycline and maltose wherein the pH of the bulk solution or solution after reconstitution is in between 3-6.
ASTRON RESEARCH Ltd | Date: 2010-03-29
ASTRON RESEARCH Ltd | Date: 2010-07-29
The present invention relates to non aqueous pharmaceutical preparations containing gemcitabine or its pharmaceutically, acceptable salts in the form of ready-to-use solutions wherein the concentration of Gemcitabine is in the range of about 16 mg/ml to about 200 mg/ml and a pH of about 3.5 to 10.0. Further, a method for the preparation of non-aqueous Gemcitabine solution of the present invention is also disclosed.