Title of the project: "Pomegranate Effervescent Granules as an Antiulcer agent"
Name of PI: DR. PRATIMA TATKE
Name of Institute: C. U. Shah College of Pharmacy
Date of proposal and funds proposed:
Date of sanction: 18/06/2016
Date of receiving grant: December 2016
Amount received: 25,00,000/-
Peptic ulcer is one of the world’s major gastrointestinal disorders and affecting 10% of the world population. An estimated 15000 deaths occur each year as a consequence of peptic ulcer. Punica granatum, commonly known as Pomegranate. The peel extracts have been proposed for their astringent, antibacterial, anti-inflammatory, antioxidant, anti-hemorrhagic, antifungal, anti-diabetic, anti-diarrheal, antiulcer and analgesic properties. The present project deals with evaluation effervescent granules containing bioactive extract of Punica granatum fruit peel.
The bioactive extract was found to be safe and effective in pre-clinical studies for hyperacidity and anti-ulcer activity in rats.
The objectives of project were:
- To conduct stability studies for Pomegranate effervescent granules (PEG) as per ICH guidelines.
- To carry out scale up studies of the formulation
- To evaluate the safety and efficacy of PEG clinically in individuals suffering from acid peptic disorders such as hyperacidity and peptic ulcers.
The project was divided into 3 parts as given below:
Part A: Stability study of PEG for 6 months as per ICH guidelines
Part B: Commercial Scale up of PEG upto 100 KG
Part C: Multicentric clinical study of PEG for acid peptic disorders (hyperacidity and peptic ulcer)
The sanctioned amount was utilized for conducting stability studies at C.U.Shah College of Pharmacy and for carrying out Multicentric clinical study on 150 patients at three different centres namely, Vishwanand Kendra, Pune, Bharati Ayurved Hospital, Bharati Vidyapeeth, Pune and M.A. Podar Medical Hospital, Mumbai. The Commercial Scale up was carried out by industry partner, Amsar Goa Pvt. Ltd. Goa.
Some of the sanctioned amount was also utilised for development and establishment of presentation room at C. U. Shah College of Pharmacy, SNDTWU and following equipments were purchased:
1. Three LCDs
2. One Laptop
3. Furniture for presentation room
4. Three Air conditioners
Significance of the presentation room:
The institute was in need of presentation room equipped with all the facilities like LCD, laptop, air conditioners and good sitting arrangement. This room is now extensively used by the college for conducting invited guest lecturers for M.Pharm. and Ph.D. students, presentation of students, PG and PhD viva, confidential meetings etc.
Outcome from project:
- The 6-month stability study confirmed that the developed was stable as per the guidelines.
- The developed and optimized containing was subjected to pilot plant and commercial scale-up up to 100 Kg. A repeatable and uniform production at pilot and commercial scale up was successfully achieved.
- A multicentric clinical study was successfully conducted at 3 centres on 150 patients. Safety and efficacy of PEG formulation was confirmed in patients with hyperacidity disorders and ulcer.
- No of students benefitted in last two years: approx. 50
Economic significance of the project:
- The Pomegranate fruit peel is an industrial/household waste.
- The present project involves technical advancement. It contributes to economic significance, by converting an industrial and domestic waste to a valuable essential medicine for treatment of hyperacidity and ulcers with substantial value-addition. Thus, a better and effective way of waste disposal.