In order to better assist researchers in their drug development efforts, BOC Sciences’ management recently decides to diversify its pharmaceutica lformulation service, which was launched about two years ago and has been well-received by clients worldwide
In order to better assist researchers in their drug development efforts, BOC Sciences’ management recently decides to diversify its pharmaceutical formulation service, which was launched about two years ago and has been well-received by clients worldwide. Now BOC Sciences provides wide range of formulation services, including formulation development, stability study, scale-up process (up to 50 kg batch size), CMC document for registration (IND) and cGMP facility for CTM manufacturing (Phase I and Phase II).
Pharmaceutical formulation is the process through which different chemical substances (such as the active drug) are combined to produce a final medicinal product. “Developing novel dosage forms such as capsules, tablets, oral solutions, suspensions and syrups has become an important current focus for pre-clinical safety evaluation within the pharmaceutical industry. BOC Sciences has significant experience in performing risk assessments. Our scientists also assist in the subsequent experimentation design, since they have a deep understanding of the parameters and quality attributes that would impact the clinical performance and safety of formulations,” explains Mr. Barron Jones, the Marketing Chief of BOC Sciences. Other factors such as manufacturability of dosage forms, and stability in primary packaging are also considered.
Usually, pre-formulation studies in combination with analytical methods are critical to identifying the best formulation strategy for a compound, “but the fact is that certain candidates often present specific challenges such as poor solubility, poor physical stability and low bioavailability and permeability. So formulation development can be helpful in overcoming many of these issues,” said Mr. Barron Jones.
Furthermore, the dosage forms that are available include: solid dosage formulations (capsules, tablets for immediate release or extended release), sterile liquid dosage formulations (ophthalmic, oral, nasal), semi-solid formulations for oral administration (syrups, suspensions), lyophilized formulations, transdermal patch, topical formulations (creams, gels), etc.
As the ICH Q8 guideline states, quality should be better built in by design. That’s why BOC Sciences always focuses on using the QbD approach on every single batch of its product. Design of Experiment (DOE), Risk Assessment Tools (RAT), Process Analytical Technologies (PAT) are extensively employed among all steps of formulation development, in a hope to ultimately improve the quality, safety and efficacy of drug product.
For more information about BOC Sciences’ integrated services on drug discovery, please visit: https://www.bocsci.com/
About BOC Sciences
To meet needs in agricultural, biotechnological, pharmaceutical and many other areas at both research and industrial scale, BOC Sciences not only offers a full-ranged collection of various chemicals, including APIs, impurities, metabolites, intermediates, inhibitor (such as hsp90 inhibitor), GMP products, ADCs, natural compounds, but also offers multiple services like chiral resolution, custom synthesis, drug discovery, CMO service are also available.