When you commission an oral solid dosage formulation development project, success depends on more than just tablet or capsule manufacture. The foundational pre-formulation characterization—API particle size distribution, polymorphic form, solubility, hygroscopicity, and stability under heat, moisture or light—must be addressed early. Missing or incomplete data in this phase often causes regulatory or performance setbacks later. According to FDA guidance, inadequate drug substance and excipient characterization in pre-formulation reports is a common issue observed in oral solid dosage form inspections.

Advanced Formulation Technology & Release Profiles

You should select a CDMO that offers a wide spectrum of formulation technologies: direct compression, wet granulation, dry granulation, coating, modified release or delayed release profiles, as well as taste masking or fixed-dose combinations. Robust coating and granulation technologies mitigate issues such as poor content uniformity or friability. If your molecule is low solubility or poor wettability, technologies like hot-melt extrusion, spray drying, or micro-/nano-particle engineering become critical.

Regulatory Strategy & Filing-Safe Development Workflows

You need formulation development executed with regulatory filing in mind—meaning your work must support NDA/ANDA or equivalent filings with fully documented control strategies, stability testing as per ICH guidelines, excipient compatibility studies, dissolution profile matching (clinical vs. commercial batch), and packaging considerations. Reports indicate that many NDA submissions are delayed due to missing stability studies or insufficient justification for coated vs uncoated dosage form choices.

Patient-Centricity and Special Population Formulations

Your drug product should consider who will take it: pediatric patients, geriatric patients, patients with swallowing difficulties, or taste sensitivities. Oral solid dosage forms such as orally disintegrating tablets (ODTs), chewables, small multi-particulates, or taste-masked granules can improve compliance in those populations. Designing these requires special excipients, sensory testing, and dosing flexibility.

Excipient Sourcing, Quality, and Supply Chain Robustness

A reliable supply of high-quality excipients, with consistency batch-to-batch, is essential. You should ensure your CDMO has qualified excipient suppliers, robust incoming material testing, and contingency sourcing options. Supply chain disruptions, changes in raw material moisture or supplier origin can affect tablet hardness, dissolution, or stability. Recent industry reports show these are among the top risks in OSD CDMO manufacturing.

Scale-Up & Tech Transfer Predictability

Scaling from R&D batches to pilot, then to commercial scale, exposes many risks: equipment differences, flow behaviour changes, compression variations, coating uniformity shifts. You need a partner who has conducted multiple full scale tech transfers for oral solids and who documents equivalence between clinical and commercial batches. That includes matching dissolution profiles, hardness, disintegration, moisture content and other critical quality attributes in both scales.

How Lianhe Aigen Enhances Oral Solid Dosage Formulation Outcomes

At Lianhe Aigen, our capabilities in oral solid dosage formulation development include pre-formulation labs capable of measuring API polymorphism, particle sizing down to our formulation & CDMO services.