Ibuprofen Formulation Development

I’m moving an ibuprofen product from concept to lab-scale prototype and need a formulation scientist who lives and breathes NSAID development. The focus is squarely on formulation and development: selecting excipients, defining the manufacturing process, and generating the data package that will let me progress toward pilot scale without re-work. Where we are now • Target product profile is sketched but flexible; I’m weighing options such as extended-release pellets, solubility-enhanced tablets, or a child-friendly suspension. • No wet-lab work has started; I’m looking for a solid formulation roadmap, prototype composition, and supporting rationale before booking bench time. What I need from you 1. Pre-formulation assessment: API-excipient compatibility, particle size, polymorph and stability considerations specific to ibuprofen. 2. Prototype design: recommended dosage form, full qualitative & quantitative formula, processing steps (direct compression, hot-melt extrusion, fluid-bed coating, etc.) and in-process controls. 3. Development plan: small-scale batch size calculations, required analytical tests (dissolution, assay, degradants, content uniformity), and indicative timelines. 4. Risk & mitigation table covering drug-excipient interactions, scale-up factors, and regulatory touchpoints (ICH, USP, FDA/EMA guidelines). 5. Concise tech report (Word + Excel) with references that will plug straight into a CMC dossier. Acceptance criteria • All data and recommendations are traceable to peer-reviewed references, pharmacopeial monographs, or prior validated work. • Prototype formula is mass-balanced and manufacturable with commonly available excipients. • Development plan includes at least two contingency pathways should the primary approach fail dissolution or stability targets. If you’ve taken an oral NSAID from ideation to clinic—or helped rescue a troubled formulation—tell me how you’d tackle this project and the tools you’ll use (e.g., Design-Expert, Minitab, WinNonlin, LC-MS). Let’s build a robust ibuprofen product that meets today’s performance and regulatory expectations.

Project ID: 40746092