The diclofenac epolamine patch used in the study had a standardized composition designed for topical pain relief. It contained 1.3% diclofenac epolamine (equivalent to 1% diclofenac free acid) as the active pharmaceutical ingredient, formulated within a hydrophilic adhesive system. The adhesive base included gelatin and polyvinyl pyrrolidone as key excipients, along with other unspecified components to optimize drug delivery and skin adhesion. This medicated layer was applied to a polyester backing material, creating a stable patch structure. Each unit measured 10 × 14 cm, providing sufficient surface area for drug absorption while allowing customization by trimming for smaller treatment areas.
Key Points Explained:
-
Active Pharmaceutical Ingredient (API) Composition
- The patch contained 1.3% diclofenac epolamine, a salt form of diclofenac designed for enhanced skin penetration
- This concentration equates to 1% diclofenac free acid, the pharmacologically active form
- The epolamine salt improves solubility and transdermal delivery compared to other diclofenac forms
-
Adhesive Matrix Formulation
- Hydrophilic adhesive base enabled moisture absorption while maintaining skin adhesion
- Gelatin provided structural integrity and controlled drug release
- Polyvinyl pyrrolidone (PVP) served as:
- Film-forming agent
- Bioadhesive component
- Solubility enhancer for the API
- "Other excipients" likely included permeation enhancers, stabilizers, and pH modifiers
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Patch Construction
- Polyester backing material offered:
- Mechanical support
- Moisture barrier properties
- Protection against external contamination
- Multi-layer design separated the drug reservoir from the backing
- Polyester backing material offered:
-
Physical Specifications
- Standard size of 10 × 14 cm (140 cm² surface area)
- Trimmable design allowed adaptation to smaller treatment areas
- Thin profile for patient comfort during wear
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Functional Characteristics
- Twice-daily application protocol
- 12-hour duration of action per application
- Targeted delivery with low systemic exposure
- Fast onset (significant pain reduction within 4 hours)
- Sustained efficacy over 7 days of consistent use
This optimized formulation balances drug delivery requirements with practical application needs, representing a sophisticated approach to topical NSAID therapy that maintains therapeutic effectiveness while minimizing systemic side effects. The composition reflects careful consideration of both pharmaceutical science and clinical usability factors.
Summary Table:
| Component | Function |
|---|---|
| 1.3% diclofenac epolamine | Active ingredient (equivalent to 1% diclofenac free acid) for pain relief |
| Gelatin & PVP adhesive base | Controls drug release, enhances solubility, and maintains skin adhesion |
| Polyester backing | Provides structural support and moisture barrier |
| 10 × 14 cm size | Optimized surface area for drug absorption, trimmable for smaller areas |
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