Solubility & bioavailability
Solid dispersions, particle-size engineering, self-emulsifying systems and surfactant screening for BCS Class II and IV molecules.
RIVANOVA
Research & Development
A 12,000 sq. ft. research centre where 42 scientists translate molecules into stable, manufacturable, patient-ready dosage forms.
Research capability
Most mid-size formulators license their dossiers. We do not — and it is the single most expensive decision we have made. It is also what allows us to answer a regulator's question about excipient compatibility in an afternoon rather than a fiscal quarter.
Our 12,000 sq. ft. research centre houses formulation development, analytical method development, packaging science and a pilot plant under one roof. A stability signal observed on Monday reaches the formulator who can act on it by Tuesday.
Scientists across formulation, analytical and packaging development.
Sq. ft. dedicated research and pilot-plant floor area.
Formulations developed and commercialised in the last three years.
Stability chambers covering ICH Zones II and IVb plus photostability.
Formulation Development Centre
Pilot plant · analytical development · packaging science
Focus areas
Solid dispersions, particle-size engineering, self-emulsifying systems and surfactant screening for BCS Class II and IV molecules.
Matrix and reservoir systems, pellet-in-capsule multi-unit particulates, and enteric protection for acid-labile actives.
Forced degradation, excipient compatibility and photostability studies that select the pack from evidence rather than convention.
Stability-indicating methods developed and validated to ICH Q2(R2) — specificity, linearity, accuracy, precision and robustness.
Taste-masking through coating, complexation and flavour systems — because an unfinished course is a failed treatment.
Documented transfer from 1× laboratory batch through pilot to full commercial scale, with process validation on three consecutive batches.
Development pathway
Typically 14 to 22 months from concept to first commercial batch, depending on the complexity of the dosage form and the regulatory pathway in the destination market.
Physicochemical characterisation of the active: solubility profile across pH, polymorphic form, hygroscopicity, particle size distribution and flow properties.
Binary and multi-component mixtures held under accelerated conditions to identify interactions before they appear in a stability study six months later.
Multiple trial formulations screened against dissolution, content uniformity and physical attributes, narrowing to two or three candidates.
A stability-indicating method is developed and validated in parallel — you cannot trust a stability result produced by an unvalidated method.
Pilot-scale manufacture followed by accelerated (6 months) and real-time stability under the destination market's climatic zone.
Formal handover to production with a transfer protocol, critical process parameters defined and operator training completed before the first exhibit batch.
Three consecutive commercial-scale batches manufactured and tested against predetermined acceptance criteria before routine production begins.
Ongoing stability commitment, annual product quality review and continued process verification for as long as the product remains commercial.
Custom formulation development, reformulation for a new climatic zone or a taste-masking challenge — our R&D team scopes projects under NDA.