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        Efficacy and tolerability of exclusive enteral nutrition in adult patients with complicated Crohn’s disease

        ( Sanchit Sharma ),( Arti Gupta ),( Saurabh Kedia ),( Samagra Agarwal ),( Namrata Singh ),( Sandeep Goyal ),( Saransh Jain ),( Vipin Gupta ),( Pabitra Sahu ),( Sudheer Kumar Vuyyuru ),( Bhaskar Kante 대한장연구학회 2021 Intestinal Research Vol.19 No.3

        Background/Aims: Exclusive enteral nutrition (EEN), an established modality for pediatric Crohn’s disease (CD) is seldomly utilized in adults. The present study reports the outcome of EEN in adult CD patients at a tertiary care hospital in India. Methods: This was a retrospective analysis of CD patients who received EEN as a sole modality/adjunct to other treatment. The primary and secondary outcomes changed in Crohn’s Disease Activity Index (CDAI), and clinical response (decline in CDAI >70), respectively, at 4 and 8 weeks. Subgroup analysis evaluated response across different phenotypes, EEN formulations and prior treatment. Linear mixed effect model was created to assess the predictors of EEN response. Results: Thirty-one CD patients received EEN over median duration of 4 weeks (range, 2-6 weeks). CDAI showed a significant improvement post EEN at 4 (baseline 290 [260-320] vs. 240 [180-280], P=0.001) and 8 weeks (baseline 290 [260-320] vs. 186 [160-240], P=0.001), respectively. The cumulative clinical response rates at 4 and 8 weeks were 37.3% and 80.4% respectively. The clinical response rates at 8 weeks across B1 (n=4), B2 (n=18), and B3 (n=9) phenotypes were 50%, 78.8%, and 100% respectively (log-rank test, P=0.093). The response rates at 8 weeks with polymeric (n=8) and semi-elemental diet (n=23) were 75% and 82.6% respectively (log-rank test, P=0.49). Baseline CDAI (odds ratio, 1.008; 95% confidence interval, 1.002-1.017; P=0.046) predicted response to EEN. Conclusions: EEN was effective in inducing clinical response across different phenotypes of CD. Baseline disease activity remained the most important predictor of clinical response to EEN. (Intest Res 2021;19:291-300)

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        Validation of aseptic processes for pharmaceuticals

        Lincy Joseph,Mathew George,Saurabh Kumar Jain 경희대학교 융합한의과학연구소 2010 Oriental Pharmacy and Experimental Medicine Vol.10 No.4

        Sterile Products may be broadly classified into two main categories, according to the manner in which they are produced: those which are sterilized after the product has been filled and sealed in the final container(s) (“terminally sterilized” products) and those where the sterilization stage (or stages) takes place is it before or after the bulk product filled in to final container. In this latter instance, all subsequent processing (typically, the filling and sealing operations) must be conducted aseptically in order to prevent recontamination of the sterilized product. The two most common pharmaceutical applications of aseptic processing methods are (a) the filling of liquid products following sterilization by filtration and (b) the filling of previously sterilized bulk powder products. An aseptic processing operation should be tested using a microbiological growth medium (media fill) during lyophilized injection formulation, filling, loading, lyophilisation, stoppering, and unloading activities.

      • Validation of aseptic processes for pharmaceuticals

        Joseph, Lincy,George, Mathew,Jain, Saurabh Kumar Kyung Hee Oriental Medicine Research Center 2010 Oriental pharmacy and experimental medicine Vol.10 No.4

        Sterile Products may be broadly classified into two main categories, according to the manner in which they are produced: those which are sterilized after the product has been filled and sealed in the final container(s) ("terminally sterilized" products) and those where the sterilization stage (or stages) takes place is it before or after the bulk product filled in to final container. In this latter instance, all subsequent processing (typically, the filling and sealing operations) must be conducted aseptically in order to prevent recontamination of the sterilized product. The two most common pharmaceutical applications of aseptic processing methods are (a) the filling of liquid products following sterilization by filtration and (b) the filling of previously sterilized bulk powder products. An aseptic processing operation should be tested using a microbiological growth medium (media fill) during lyophilized injection formulation, filling, loading, lyophilisation, stoppering, and unloading activities.

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