Background and Objectives: The present study unveils a simple but innovative combination of existing treatments of three different domains with unique logical aspects. Joint pain is the major cause of disability, especially for older adults. Currently, two widely practiced treatment options are combined to produce simultaneous treatments that overcome the drawbacks of individual treatment and improve patient compliance. Moreover, a third treatment option of cooling and counterirritant material (Menthol) for pain relief was also explored successfully as a substitute treatment.
Methods: In the present study, we formulated and optimized an adhesive topical patch of the model drug diclofenac sodium, a widely used medicine for pain relief and menthol, a cooling and counterirritant substance to aid pain relief. Combinations of two polymers, PVP-K30 and PVA, selected by trial batches, were further optimized by applying a 3x2 full factorial design. Two factors, X1 (PVPK30) and X2 (PVA), were optimized using three responses, R1 (Q2), R2 (Q4), and R3 (Q12). Derived mathematical models for responses were validated using checkpoint batches. The final optimized batch was derived based on the desirability function. Factorial batches were also evaluated for relevant parameters.
Results: Results obtained by checkpoint batches were in line with the experimental results with 5% relative error, revealing that the derived models were valid for the design. The final optimized batch obtained by the desirability function followed all set criteria. Medicated patch prepared by optimized formulation was incorporated into the knee brace using an in-house patch holder mechanism.
Conclusion: Combined treatment offers better patient compliance for the patient and the healthcare provider, which can be extended to other pain-relieving supportive treatments like elbow braces, waist brace, back support belt, cervical brace, etc.
Keywords: Diclofenac sodium, menthol, non-surgical, PVA, PVP-K30, supportive treatment, knee braces.