A Stability Study of Ayurvedic Laxative Formulation – Constac Granulation
📅 2015Published in International Journal of Ayurveda and Pharma Chemistry
🕒 Approx. 3 min read | 👥 Dr. Ashwin Porwal, Healing Hands Clinic
AP
Dr. Ashwin Porwal
MS (Gen. Surgery) • Founder & Chief Surgeon, Healing Hands Clinic • India’s leading proctologist with 25+ years of clinical experience, 6 patents, and 60+ peer-reviewed publications. Pioneer of minimally invasive colorectal surgery in India.
📄 About This Publication
This stability study evaluated the physicochemical and microbiological stability of Constac granules — the patented Ayurvedic laxative formulation developed at Healing Hands Clinic — under real-time and accelerated storage conditions following ICH (International Council for Harmonisation) guidelines Q1A(R2).
Parameters evaluated included physical appearance, colour, odour, hygroscopicity, flow properties (angle of repose, bulk density), moisture content, active constituent assay, pH, disintegration time, and microbial limit testing.
The study confirmed that Constac granules maintained their physicochemical integrity and microbiological safety across all storage conditions tested, supporting the assignment of a defined shelf-life and appropriate storage recommendations for commercial packaging and distribution.
✓ Key Findings & Clinical Significance
✔ ICH Q1A(R2) compliant stability protocol
✔ Real-time and accelerated storage conditions tested
✔ Parameters: appearance, moisture, active assay, flow, microbial limits
✔ Supports commercial shelf-life assignment for Constac granules
✔ Essential regulatory data for Ayurvedic product registration
ⓘ Publication Details
Stability Study
2015
International Journal of Ayurveda and Pharma Chemistry
Q: Why is a stability study important for herbal formulations?
Stability studies confirm that a herbal product retains its potency, safety, and physical form throughout its assigned shelf life — critical for both regulatory approval and patient safety.
Q: What conditions were used in this stability study?
The study used ICH-recommended accelerated conditions (40°C/75% RH) and real-time conditions (25°C/60% RH) to predict long-term product stability.
Q: What is the shelf life of Constac granules?
The assigned shelf life is detailed in the published article based on stability data collected across the study duration.
Healing Hands Clinic is India’s largest network of dedicated proctology and colorectal surgery centers, with 50+ locations across India and Dubai. Founded by Dr. Ashwin Porwal, the clinic specialises in minimally invasive treatments for piles, fissures, fistulas, rectal prolapse, constipation, and related colorectal conditions. NABH accredited, serving over 1 lakh patients annually since 2004.
Healing Hands Clinic is India’s most trusted center of excellence for proctology, specializing in advanced, minimally invasive laser treatments for anorectal conditions. Founded by Dr. Ashwin Porwal, a pioneer who introduced laser proctology to India, the clinic provides world-class, focused care for ailments like piles, fistulas, fissures, pilonidal sinus, and chronic constipation. Utilizing state-of-the-art infrastructure and modern techniques like DLPL, they prioritize treatments that provide minimal pain, negligible recurrence rates, shorter hospital stays, and quicker recovery.
Disclaimer : The information on this site should not be considered as medical advice. Please consult a doctor for determining the best procedure as well as the most appropriate for your proctological needs.