Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.

Importance of obtaining a stable homogeneous mixtures with micronized APIs

There are several reasons to micronize APIs in a solid-dosage formulation. Many new drug molecules are poorly soluble and one means to enhance solubility is to enlarge the surface area by micronizing the API. To Achieve a homogeneous mixture of the micronized API and excipients in a solid dose and maintaining product stability, however, can be challenging. Additionally, micronized APIs are used in the formulation of highly potent drugs that require low dosage. In this case, content uniformity is crucial and difficult to achieve when seeking to evenly distribute content of less than 1% API within a solid formulation.

Generally, conventional mixture doesn’t give good stability of homogeneity. This is what the statistics have shown. For this reason, many formulators switch to more expensive wet or dry granulation processes instead of direct compression (DC) or sachet formulations. We recommend that the homogeneity of mixing be improved instead of diversifying the process. The homogeneous mixing dynamics of API powders with the Alphie 3D Mixer have been proven and Alphie is becoming known in pharma industries as the homogeneous API powder mixer. We have a range of pharmaceutical powder mixers e.g. for homogeneous mixing in the laboratory one can go for the Alphie Laboratory Capacity Mixer Model and for production purposes, one can consider the Alphie production capacity mixer models. In addition, we also have customized design mixer models which can give liquid dosing during mixing.

We Offer Three Dimensional (3D) multi motion mixers having various capacity ranges from 3Ltr to 1500Ltr mixing capacity.