Hydroxy propyl β-cyclodextrin complexation of promethazine hydrochloride for the formulation of fast dissolving sublingual film: in vitro and in vivo evaluation

Jigar N. Shah,Kashyap N. Shah,Tejal A. Mehta 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.1

Promethazine hydrochloride (PMZ-HCl) is a classical anti-motion sickness drug which has oral bioavailability (25 %) due to extensive hepatic first pass metabolism. To overcome this drawback, novel, fast dissolving sublingual film (FDSF) of drug was developed. FDSF was formulated using pullulan and propylene glycol (PG) by solvent casting method. Complete taste masking was successfully obtained with HP β-CD, aspartame and grape fruit flavour. Complex of drug was proved using Fourier transfer infrared spectroscopy, differential scanning calorimetry and X-ray diffraction studies. Optimization of concentration of pullulan and PG was done using 32 full factorial design. Batches were evaluated for the parameters like elongation, tensile strength, folding endurance and in vitro disintegration studies. In vitro dissolution indicated 100 % drug release within 7.5 min. Environmental scanning electron microscopy studies also showed uniform drug distribution and integrity of film. In vivo sublingual absorption in human indicated that 70 % of drug absorbed in 10 min. The stability studies indicated that label should state ‘‘Store at cool, dry place’’ at temperature 25 ˚C. So by formulating the taste masked FDSF of PMZ-HCl will give faster onset of action and avoid unnecessary drug intake leading to traveller friendly formulation.

Emerging role of nanosuspensions in drug delivery systems

Shery Jacob,Anroop B. Nair,Jigar Shah 한국생체재료학회 2020 생체재료학회지 Vol.24 No.1

Rapid advancement in drug discovery process is leading to a number of potential new drug candidates having excellent drug efficacy but limited aqueous solubility. By virtue of the submicron particle size and distinct physicochemical properties, nanosuspension has the potential ability to tackle many formulation and drug delivery issues typically associated with poorly water and lipid soluble drugs. Conventional size reduction equipment such as media mill and high-pressure homogenizers and formulation approaches such as precipitation, emulsion-solvent evaporation, solvent diffusion and microemulsion techniques can be successfully implemented to prepare and scale-up nanosuspensions. Maintaining the stability in solution as well as in solid state, resuspendability without aggregation are the key factors to be considered for the successful production and scale-up of nanosuspensions. Due to the considerable enhancement of bioavailability, adaptability for surface modification and mucoadhesion for drug targeting have significantly expanded the scope of this novel formulation strategy. The application of nanosuspensions in different drug delivery systems such as oral, ocular, brain, topical, buccal, nasal and transdermal routes are currently undergoing extensive research. Oral drug delivery of nanosuspension with receptor mediated endocytosis has the promising ability to resolve most permeability limited absorption and hepatic first-pass metabolism related issues adversely affecting bioavailability. Advancement of enabling technologies such as nanosuspension can solve many formulation challenges currently faced among protein and peptide-based pharmaceuticals.

Development of a monoclonal antibody-based coagglutinationtest to detect enterotoxigenic Escherichia coliisolated from diarrheic neonatal calves

Brajesh C. Varshney,N.M. Ponnanna,Pranati A. Sarkar,Pragna Rehman,Jigar H. Shah 대한수의학회 2007 JOURNAL OF VETERINARY SCIENCE Vol.8 No.1

Escherichia coli (E. coli) strains were collected from young diarrheic calves in farms and field. Strains that expressed the K99 (F5) antigen were identified by agglutination tests using reference antibodies to K99 antigen and electron microscopy. The K99 antigen from a selected field strain (SAR-14) was heat-extracted and fractionated on a Sepharose CL-4B column. Further purification was carried out by sodium deoxycholate treatment and/or ion-exchange chromatography. Monoclonal antibodies to purified K99 antigen were produced by the hybridoma technique, and a specific clone, NEK99-5.6.12, was selected for propagation in tissue culture. The antibodies, thus obtained, were affinity-purified, characterized and coated onto Giemsastained Cowan-I strain of Staphylococcus aureus (S. aureus). The antibody-coated S. aureus were used in a coagglutination test to detect K99+ E. coli isolated from feces of diarrheic calves. The specificity of the test was validated against reference monoclonal antibodies used in co-agglutination tests, as well as in ELISA. Specificity of the monoclonal antibodies was also tested against various Gram negative bacteria. The developed antibodies specifically detected purified K99 antigen in immunoblots, as well as K99+ E. coli in ELISA and co-agglutination tests. The co-agglutination test was specific and convenient for large-scale screening of K99+ E. coli isolates.

Performance Evaluation of Water Supply Services in Developing Country: A Case Study of Ahmedabad City

S.M. Yadav,N. P. Singh,Kalpana A. Shah,Jigar H. Gamit 대한토목학회 2014 KSCE Journal of Civil Engineering Vol.18 No.7

Unplanned and rapid growth of urban areas of developing countries poses major threat to service providers. Water supply management becomes critical aspect in the above scenario. The onus of managing its supply and distribution rests on the local government of the concerned area. Ahmedabad being world’s third largest and India’s fastest growing city has been selected for analysis of water supply services. Performance evaluation of water supply services for Ahmedabad city was carried out using nine performance indicators suggested by Ministry of Urban Development (MOUD), Government of India. The nine performance indicators as suggested by MOUD are: coverage of water supply connection, per capita supply of water, extent of metering of water connections, extent of non revenue water, continuity of water supply, quality of water supplied, efficiency in redressal of customer complaints, cost recovery of water supply services and efficiency in collection of water supplied related charges. Required data was collected from Ahmedabad Municipal Corporation. Analysis of the data suggests that among all the indicators of supply of water, cost recovery in water supply services, efficiency in redressal of customer complaints, quality of water supplied and efficiency in collection of water supply related charges showed good performance. However, metering of connection, continuity of water supply and non revenue water needs planned efforts to bring them up to the benchmark.

Neoadjuvant chemoradiotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: Meta-analysis and trial sequential analysis of randomized controlled trials

Shahab Hajibandeh,Shahin Hajibandeh,Christina Intrator,Karim Hassan,Mantej Sehmbhi,Jigar Shah,Eshan Mazumdar,Ambareen Kausar,Thomas Satyadas 한국간담췌외과학회 2023 Annals of hepato-biliary-pancreatic surgery Vol.27 No.1

We aimed to compare resection and survival outcomes of neoadjuvant chemoradiotherapy (CRT) and immediate surgery in patients with resectable pancreatic cancer (RPC) or borderline resectable pancreatic cancer (BRPC). In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards, a systematic review of randomized controlled trials (RCTs) was conducted. Random effects modeling was applied to calculate pooled outcome data. Likelihood of type 1 or 2 errors in the meta-analysis model was assessed by trial sequential analysis. A total of 400 patients from four RCTs were included. When RPC and BRPC were analyzed together, neoadjuvant CRT resulted in a higher R0 resection rate (risk ratio [RR]: 1.55, p = 0.004), longer overall survival (mean difference [MD]: 3.75 years, p = 0.009) but lower overall resection rate (RR: 0.83, p = 0.008) compared with immediate surgery. When RPC and BRPC were analyzed separately, neoadjuvant CRT improved R0 resection rate (RR: 3.72, p = 0.004) and overall survival (MD: 6.64, p = 0.004) of patients with BRPC. However, it did not improve R0 resection rate (RR: 1.18, p = 0.13) or overall survival (MD: 0.94, p = 0.57) of patients with RPC. Neoadjuvant CRT might be beneficial for patients with BRPC, but not for patients with RPC. Nevertheless, the best available evidence does not include contemporary chemotherapy regimens. Patients with RPC and those with BRPC should not be combined in the same cohort in future studies.