Pre-formulation studies help identify drug–excipient interactions early and reduce risk during formulation development. Pre-formulation includes solubility and chemical compatibility assessments to determine achievable drug concentration, identify unsuitable excipients, and assess the need for stabilization strategies.
These studies define the formulation strategy and guide downstream development
MedPharm’s formulation development strategy is tailored to client-specific risk, budget, timelines, and scope. Our Subject Matter Experts design formulations using pre-formulation data, the target product profile, and specific program needs.
Development follows Quality by Design (QbD) principles in line with ICH Q8 to reduce risk and control costs across the development lifecycle.
This approach has supported nearly three-quarters of recently approved topically applied New Chemical Entities (NCEs) by the FDA.
Our formulation development focuses on:
Topical products use a wide range of packaging and delivery systems, from simple tubes to complex metered-dose devices.
Device and packaging selection depends on formulation type, product complexity, and whether the product is classified as a drug–device combination. When the device plays a critical role in drug delivery, it is integrated into development activities early.
MedPharm incorporates IP considerations throughout formulation and process development.
While early patents often approach expiry by market launch, our approach supports additional IP generation through formulation composition and manufacturing strategy. MedPharm has a 100% success rate supporting IP generation when required.
MedPharm utilizes advanced formulation characterization instrumentation to evaluate physical properties, stability, and performance of topical and transdermal drug products. These capabilities support data-driven formulation development from early-stage research through scale-up.
| Texture Analyzer | Viscometers & Rheometers |
|---|---|
| Stable Micro Systems TA.XT PlusC | TA Instruments HR-1 Discovery Hybrid Rheometer |
| TA Instruments HR-2 Discovery Hybrid Rheometer | |
| Brookfield RVDVNext |
| Physical Testing | |
|---|---|
| InVia Qontor Raman microscope | Olympus BX53M microscope |
| Sympatec HELOS/KR laser diffraction particle sizer | Mettler Toledo S220 Seven Compact pH/ion |
| LUMiSizer Dispersion Stability Analyzer | Metrohm Karl Fischer |
| Osmometer | Next Generation Impactor (NGI) |
| Dosage Unit Sampling Apparatus (DUSA) |
Established in 1999, MedPharm brings over 25 years of expertise in topical and transdermal drug development. Our teams are widely recognized by global regulatory authorities as Subject Matter Experts and have contributed to EMA guidance on formulation development and product characterization.
Scientific staff undergo rigorous qualification and support:
MedPharm SMEs have published multiple papers/reviews and books around formulation development, including but not limited to the following:
