Description : | In an endeavour to make available high quality and innovative products inIndia, CSIR-IIIM Jammu initiated to conduct the Phase I Clinical trial titled "A Phase- I, Dose escalation study to evaluate safety, tolerability and Pharmacokinetic of ICB014 A002, Herbal Capsule in healthy adultvolunteers" in collaboration with one of the Indian CRO company at Apollohospitals, Ahmadabad, Gujarat with registered Clinical trial Registry ofIndia (CTRI) bearing number CTRI/2018/01/011259 dated: 10/01/2018. Inaddition to the above, Apollo Ethics committee approved the proposedstudy to conduct the same on conditionally. As per current status of thestudy, it is informed that, Phase- I Clinical trial studies (DoseEscalation Study to evaluate safety, tolerability and pharmacokineticof ICB-014-A002 capsule) was successfully completed. The presentinvention technology comprises an effective amount of an extract/lyophilized (Hydro alcoholic) extract along with one or morepharmaceutical acceptable additives/carriers.In this review, attempts have been made to identify some medicinal plantswhich may be used in ayurveda as well as modern science for thetreatment or prevention of peptic ulcer. With this background data, IIIM,Jammu has developed standardized drug product i.e., ICB 014-A002Capsule. The manufacturing procedure has been scaled up (in cGMPfacility) and all the manufacturing process has been optimized. Analyticalmethod for drug substance: and Drug product has been developed andvalidated at QC/QA section, IIIM Jammu. Drug Product was found to bestable when stored at 40°C ± 2°C Technology Demonstration5% ± 5% RH for 6 months and 30°C± 2°C 65% ± 5% RH for 18 months in PVC bottle pack. This invention envisagesthe potential of an extract obtained from the flower of the plant to act as aneffective therapy against peptic ulcer disease (Indication: Anti- Ulcer).IIIM Jammu, ICB014 A002, Herbal capsule formulation with trademark/brand name under Trade Mark (TM) class 5, registered withController General of Patents Design Trade marks, as "Ulcrine" andsame was accepted advertised by the said authority on 23/04/2018. |