Pharmaceutical formulation development is key to determining the optimal dosage form, composition, and manufacturing route for a pharmaceutical product. Cost pressures are driving a need for more rapid drug development processes which include the selection of an effective formulation. Achieving a robust drug formulation by observing the principles of QbD enhances overall drug product performance and the resultant stability of complex dosage forms, whilst concurrently enabling less complex scale-up activities. In particular, orally inhaled and nasal drug products can present unique formulation challenges when considering control of key quality attributes of in vitro and in vivo performance.
Our drug product formulation development teams offer design and optimization of formulations for powders, capsules, liquids and solids, soft gel, semi-solids, inhaled, nasal, nebulized, Pressurized and topical drug formulations.
Our expertise helps accelerate project timelines and includes pre-formulation, excipient-API compatibility assessment and optimization, physicochemical testing, formulation screening, lab-scale formulation and accelerated stability studies to achieve the desired product characteristics.
Prior to pre-clinical studies we can offer a broad range of analytical capabilities including solubility assessment, dissolution, solid state characterization, particle morphology, forced degradation and stability screening, in order to select the optimal development candidates.
The approach taken by the neutron pharma chemical formulation development team enables small quantities of drug product to be developed using experimental design methodologies supported by testing at every stage. By integrating screening, analysis and stability storage, our specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify the most promising candidates to progress through to clinical development. As a result, we can save you time by reducing method and technology transfer time as well as effort.
With a holistic approach to service provision including raw material quality control, scale-up, pilot scale batch manufacturing and testing, stability storage, impurities testing, as well as release testing with QP release, we offer a one-source solution for materials supplies for use With dedicated teams of highly experienced analysts and specialist formulation and process development scientists, we offer a truly flexible service which will help you develop the optimal formulation and manufacturing processes for your drug product. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards
Neutron IQ/OQ documentation was founded on the following documentation tree
Regular calibration of instruments is commonplace for process manufacturers. But in the Pharmaceutical industry particularly
These types of training methods do not make a full list, but they are the general methods that might be divided into sub-categories
GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process.