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Preformulation and Formulation

Sundia fully understands that preformulation and formulation development activities are critical to the success of your drug candidate. We at Sundia provide full range of service modules aiming to provide "One-Stop Shop" formulation/product development services to meet clients' development needs at various stages. The service modules include drug discovery support, preformulation, formulation and process development, analytical development, stability testing and clinical trial material manufacturing through to product registration services. The integration of these services helps to move your drug candidates quickly and seamlessly from preclinical to regulatory filings.

Our preformulation group is skilled in a wide range of analytical approaches to choose the correct form of your drug substance, evaluate its physical properties, and generate a thorough understanding of the material's stability under various conditions, leading to the optimal downstream formulation and product development.

Our formulation group is highly experienced in developing most conventional solid and liquid dosage forms and novel formulations, drug delivery systems (e.g. sustained/controlled release, water insoluble drug formulations, etc.).

Sundia works closely with its clients in designing and conducting preformulation and formulation development activities. Depending on the nature of your drug candidate, Sundia can conduct special studies expanding the project scope operating under the Rigid + Flexible (R&F) philosophy (Rigid = stringent internal SOPs and cGMP requirement; Flexible = flexible service philosophy to adapt to client requirement).

Drug discovery support
• Physical-chemical evaluation of selected chemical leads to enable the selection of optimal development candidates;
• Microscale drug characterization and evaluation;
• Exposure-enhancing formulations for activity/efficacy, pharmacokinetics and toxicology evaluations;
• Drug developability assessment.

Preformulation study
• Physical pharmacy profiling: pH-solubility, pH-stability, solubility in lipids, surfactants/polymers, partition coefficient (logP, logD), solid state characterization, solid state stability, solution stability;
• Dissolution and intrinsic dissolution rate;
• Polymorph form screening and selection;
• Salt form screening and selection;
• Early formulations for PK, PD and toxicological evaluation;
• Powder characterization: compactability, process induced form conversion, flow, particle size evaluation and specification recommendation;
• Drug excipient compatibility.

Formulation and product development
• Formulation screening using stability, dissolution and animal PK;
• Process selection based on physicochemical and physical properties of the drug candidate;
• Scale up process design and optimization;
• Establish product specifications based on pre-formulation and formulation data;
• Multimedia dissolution testing and dissolution method development;
• Packaging, storage and shipping conditions evaluation and selection;
• Technology transfer of formulation and manufacturing process to clinical supply manufacturing sites;
• CMC package for IND/NDA/ANDA filing documents;

Clinical trial material manufacturing
• Capsules, tablets and oral liquids formulations to support up to phase 2 in cGMP compliant facility;
• Clinical support material: powder in bottle (PIB), powder in capsule (PIC);
• Supporting documentation, including detailed formulation development, stability reports, specification document;
• Global filing documents for phase II trials

Instrument and equipment highlights
• Rotary tablet press (19 stations)
• Bilayer rotary tablet press (14 stations, B/D turret)
• High shear vertical granulators (1L ~ 25L)
• Fluid bed granulator, dryer and granulator (1L ~ 10L)
• Extruder and spheronizor
• Roller compactor
• Quadro Comil
• Perforated pan coater (1.5L ~ 8L)
• Automatic capsule filler (for solids, liquids and semi-solids) and capsule sealer
• Powder X-Ray diffraction (Powder XRD)
• Differential Scanning Calorimetry (DSC)
• Thermal Gravimetric Analysis (TGA)
• Dynamic moisture vapor sorption (DVS)
• Dissolution stations with online UV detector, auto-sampler

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