ABSTRACT

The bilayer oral strip is a suitable and pleasant delivery method, facilitating easy administration for pediatric patients. Pregabalin, acting on voltage-gated calcium channels and specifically binding to the ?2-? subunit, was explored for formulating such a strip. With each layer disintegrating rapidly, the first layer aims for immediate drug release to swiftly alleviate neuropathic pain (characterized by burning and shooting sensations), while the second layer provides sustained release to prevent recurrent attacks for a specified duration. Utilizing casting and double casting techniques ensured that the bilayer film exhibited the essential both physical and mechanical attributes. Various plasticizers were mixed with a spectrum of hydrophilic and hydrophobic polymers in varying ratios and concentrations. Their impacts on variables including mechanical characteristics, in-vitro disintegration time, and release profile were thoroughly investigated. The optimized formula (F5) demonstrated a disintegration time of 25 seconds, releasing 90% of the drug within the initial 6 minutes, followed by sustained release for up to 3 hours. The quick release profile and the commercially available oral Pregabalin tablet were compared. The film remained stable for 3 months as per ICH Q1A (R2) guidelines. In an in vivo study with rats, the drug's bioavailability increased 663.9-fold and reached systemic circulation within 15 minutes. Keywords: Child-appropriate dosage form, Pregabalin, Oral Bilayer Film, Sustained Release, factorial design, In vitro Release kinetics study, stability study, in vivo animal study
Publication date: 01/02/2026

https://ijbpas.com/pdf/2026/February/MS_IJBPAS_2026_9747.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.2.9747