Ibuprofen Formulation Development
Budget / Salary₹600–1,500
TypeFreelance project
LocationRemote
Posted2 hours ago
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.
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.
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