Content Uniformity

Low dosage products (under 10mg) can often give rise to low content uniformity.  For tablet and powder formulations it is often very difficult to achieve an acceptable uniformity.  Encap has worked with clients on many projects with the aim of improving the dose homogeneity of the client's formulation.

Liquid fill formulations, as solutions or suspensions, in general provide better dose homogeneity and fill accuracy compared to powder fill capsules or tablets.  They are often the formulation of choice for low dose products.  In addition, liquid fill capsules generally require less API and excipients compared to other formulations by comparison, thus minimising API requirements in both the early stages of drug product requirement and clinical manufacture.  These formulations are also very scalable ensuring a smooth and speedy transition from bench scale to commercial scale when required. 

Encap has considerable experience of developing uniform, formulations for doses as low as 250 micrograms.

Potent Product Manufacturing 

Drug products that are intended for use in low doses are generally difficult to produce in a solid oral dosage form.  The highly potent nature of such drugs (cytotoxic agents, hormones, etc) means that they carry increased risks of cross contamination and can expose operaters to harmful dust during manufacture.  Incorporating these APIs into a dust free liquid or semi-solid formulation is a valid alternative which protects against these risks.  Encap is able to offer full high potency development and manufacturing capability to our clients through a new high containment facility that was completed in 2009. Find out more about our high containment manufacturing.