Preformulation, Drug–Polymer Compatibility and Analytical Method Validation for an Antidiabetic Dissolving Microneedle Patch

Shakshi Sharma; Prof (Dr.) Sushila Kalra; Prof (Dr.) Neetesh Kumar Jain

doi:10.36948/ijfmr.2026.v08i05.88168

Preformulation, Drug–Polymer Compatibility and Analytical Method Validation for an Antidiabetic Dissolving Microneedle Patch

Author(s)	Ms. Shakshi Sharma, Prof (Dr.) Sushila Kalra, Prof (Dr.) Neetesh Kumar Jain
Country	India
Abstract	Abstract: Dissolving polymeric microneedle patches offer a minimally invasive means of transporting antidiabetic molecules across the stratum corneum, but their development requires more than selecting a soluble polymer and demonstrating needle formation. The active pharmaceutical ingredient must remain stable during solution preparation, mould filling, drying, demoulding and storage; the polymer system must provide adequate rheology, mechanical strength, insertion and rapid hydration; and the analytical procedure must quantify the drug accurately in casting solutions, dry patches, skin extracts and permeation samples. This article presents an integrated framework for preformulation, drug–polymer compatibility assessment and analytical method validation for an antidiabetic dissolving microneedle patch. It describes drug-selection criteria, identity and solid-state characterization, solubility and ionization studies, partition behaviour, hygroscopicity, thermal analysis, spectroscopy, binary-mixture stress studies and compatibility decision-making. It then discusses analytical target profiles, UV–visible and chromatographic method development, matrix-specific sample recovery and validation according to ICH Q2(R2). Particular attention is given to the distinction between absence of a visible incompatibility and evidence of compatibility, and between high nominal drug content and accurate delivered-dose measurement. The paper proposes a risk-linked workflow in which analytical capability is established before formulation optimization and is challenged in all matrices relevant to microneedle manufacture and performance testing. This approach supports scientifically defensible formulation selection, data integrity and later scale-up without claiming unverified experimental results.
Keywords	Keywords: preformulation; drug–polymer compatibility; dissolving microneedles; antidiabetic drug; analytical target profile; method validation; ICH Q2(R2); transdermal delivery
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-09-22
DOI	https://doi.org/10.36948/ijfmr.2026.v08i05.88168

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Preformulation, Drug–Polymer Compatibility and Analytical Method Validation for an Antidiabetic Dissolving Microneedle Patch

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