Pharmatrans excipients for improved compactibility and flowability in tablet manufacture

Pharmatrans SANAQ AG specializes in pharmaceutical excipients and active ingredients, harnessing a spirit of innovation and commitment to high quality products based on a solid platform of experience established over almost four decades.

The Pharmatrans SANAQ product portfolio includes a range of high quality co-processed pharma excipients optimized for compactibility and flowability to ease problems in full scale production of tablets and other oral solid dosage (OSD) forms.

What is an excipient?

In tablet manufacturing it is possible to define excipient as a non-active substance, usually in powdered form, added to the active pharmaceutical ingredient (API) of the formulation to increase its bulk, improve its stability, and dilute the concentration of API to optimize its therapeutic properties, such facilitating drug absorption, reducing viscosity, or enhancing solubility. Excipients can also be called “bulking agents”, “fillers”, or “diluents”.

Tablet excipient properties are also important in the direct compression and other tablet manufacturing processes, in optimizing the flowability and compactibility of the powdered formulation as it moves through roller compaction and tablet press, etc., to prevent problems such as sticking and clogging and ensure target tablet hardness and integrity.

Flowability can be defined as the propensity of the powder to flow smoothly into and through a tablet press while compactibility (often mis-spelled as ‘compactability’) defines the finished tablet’s tensile strength as a function of its solid fraction. This is distinct from compressibility, which measures how readily the material undergoes a change in volume when compressed.

Each Pharmatrans SANAQ excipient is carefully formulated to provide the ideal blend of properties to support particular tableting and other manufacturing applications.

Pharmatrans SANAQ co-processed excipients portfolio

The Pharmatrans SANAQ excipients list includes four co-processed powder formulations optimized for particular applications.

• SANAQ® SL 004: This co-Processed excipient is based on a mix of Lactose monohydrate and sodium starch glycolate. It is designed for direct compression (DC or DICOM) providing help to improve tablet hardness, faster disintegration, and superior flowability, making tablet disintegration independent of tablet hardness and lubricant level. SANAQ SL 004® has an average particle size distribution (PSD) of 300 – 550 microns and shows excellent and superior free powder flow properties compared with physical mixtures in same ratio of components that showing very poor flow properties.
• SANAQ® ML 011: This co-processed excipient is based on lactose monohydrate and cellulose micro crystalline, with an average PSD of 300 – 550 microns. Its properties promote a smooth surface of resulting tablets, with superior tablet hardness and powder flowability. ML 011 provides an excellent compaction excipient for sensitive APIs and is also useful excipient for low dosage formulations. It offers high weight consistency at all compaction speeds, promoting more consistent tablet hardness. It shows excellent and superior free powder flow compared with physical mixture in same ratio of components that exhibit very poor flow properties.
• SANAQ® SP 204: A co-processed excipients blended from microcrystalline cellulose (MCC) based co-processed excipient along with diluent, desiccant, disintegrant and alkaline stabilizer, with average PSD of 300 – 600 microns. SANAQ® SP 204 is especially tailored to help formulation development of moisture sensitive APIs and in powders where alkaline conditions need to be controlled to maintain stability of the formulation. It also has excellent and superior flow properties compared to simple physical blends on all the key parameters such as bulk density, repose angle, Hausner ratio and Carr index. SANAQ® SP204 also exhibits high bulk density making it suitable for formulation of high weight tablets.
• SANAQ® SP 205: This is a microcrystalline cellulose (MCC) based excipient, co-processed with colloidal silicon dioxide (CSD), binders and disintegrants, with average PSD of 300 – 600 microns. It is tailor made for moisture sensitive and low bulk density / fluffy API’s, showing superior flow properties to simple physical blends on all the key flowability parameters such as bulk density, repose angle, Hausner ratio and Carr index.

Resources

Click on DICOM SANAQ portfolio for a summary of available blends.