Phase-Stable Acyclovir Hydrocortisone Topical Cream
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Solution Overview
Problem
Conventional formulations of acyclovir and hydrocortisone suffer from phase separation issues at elevated temperatures and humidity, leading to instability and reduced efficacy in topical applications, which affects the treatment of herpes virus infections.
Innovation Solution
A topical cream composition comprising 7.5-12.5% isopropyl myristate and 10-15% cetostearyl alcohol is developed to maintain phase stability at 40°C±2°C and 75%±5% relative humidity for at least 3 months, ensuring effective delivery of acyclovir and hydrocortisone without phase separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional formulations of acyclovir and hydrocortisone are used, then the composition can be prepared with simple ingredients, but phase separation occurs at elevated temperatures and humidity leading to instability
Solution Approach 1:
The patent applies composite materials by combining multiple excipients (isopropyl myristate, cetostearyl alcohol, propylene glycol, white soft paraffin, liquid paraffin) with the active ingredients acyclovir and hydrocortisone to create a stable emulsion system. This composite formulation prevents phase separation at elevated temperatures and humidity while maintaining therapeutic efficacy, resolving the contradiction between stability and formulation simplicity.
2Duration of action of stationary object
If the composition is stored at elevated temperature and humidity for extended periods, then long-term stability is tested, but phase separation occurs reducing therapeutic efficacy
Solution Approach 1:
The patent applies beforehand cushioning by incorporating stabilizing excipients (isopropyl myristate, cetostearyl alcohol, propylene glycol) that preemptively prevent phase separation during extended storage at elevated temperatures and humidity. These ingredients create a robust emulsion system that maintains structural integrity and therapeutic efficacy throughout the storage period, cushioning against the harmful effects of environmental stressors.
3Ease of manufacture
If simple conventional excipients are used, then manufacturing is easier, but the composition fails to maintain phase stability under accelerated storage conditions
Solution Approach 1:
The patent applies parameter changes by optimizing the concentrations of specific excipients: isopropyl myristate (7.5-12.5%), cetostearyl alcohol (10-15%), propylene glycol (15-20%), white soft paraffin (40-50%), and liquid paraffin (10-20%). These parameter optimizations create a balanced formulation that is both manufacturable with standard procedures and stable under accelerated storage conditions, resolving the contradiction between ease of manufacture and phase stability.
Data Source
AI summary
The present invention provides a phase stable topical formulation of an antiviral substance, 5% acyclovir, and an anti-inflammatory glucocorticoid, 1% hydrocortisone,wherein the formulation comprises 7.5-12.5% (w/w) of isopropyl alkanoic acid ester and 10.0-15.0% (w/w) of cetostearyl alcohol, and methods of preparing the same.The composition exhibits storage stability, especially phase stability, at a temperature of about 40°C±2°C and relative humidity of about 75%±5% for a period of at least 3 months.