BOC Sciences is committed to providing modern, state-of-the-art pharmacy laboratories and facilities including formulation, manufacturing, and drug delivery.
BOC Sciences' bioanalytical laboratories work in a Good Laboratory Practice (GLP) compliant environment, providing method development, transfer, validation and analysis of pre-clinical and clinical biological samples.
BOC Sciences' clinical pharmacokinetics laboratory can support pre-clinical and clinical research programmes through the development and utilisation of bioanalytical methods.
To develop a formulation that accommodate drug product manufacture to improve drug bioavailability from 60ng/ml to 80+ng/ml.
Solution:
The flow optimize is the first priority, we need to ensure the uniformity of the content of the active substance. Second, we need to improve efficiency during the packaging of the pre-existing product.
Related research will be conducted on the formulation development (optimization of excipients ratio, evaluation of active substances from different batch) and on the process parameters (blending speed, time and flow-ability). It is possible to obtain the blending parameters by the industrial reference process. The qualitative/quantitative analysis data is obtained through NIR profile and UPLC analysis. NIR profile can be used to study the correlation of powder flow-ability and type of active substances. The parameter correlations can be used in the next industrial scale up stage. Using a mathematical approach and the in-line control to determine blending uniformity, flow-ability, repose angle and density. The statistical evaluation is used to analysis and then conduct the optimization process. The blend's flow-ability is usually depended on the particle size of the active substance. Moreover, active substances from different suppliers have different physical properties that will also influence the blending process.
To develop a fixed-dose combination (FDC) drugs that was safe, effective and stable for treatment of the specific treatment regimen.
Solutions:
Preliminary clinical studies. It has been accepted that most drugs should be formulated as single compounds. There is an example of a FDC HIV drug: ATRIPLA® is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), which is a combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. FDC drugs can help improve adherence by reducing the pills taken each day.