Formulating with matrix-controlled release excipients
Well known for acetylenics, cellulosics and film coatings, Ashland’s polymers have a rich and diverse history supporting active pharmaceutical ingredient delivery.
Using careful design and compositional selection, Ashland’s scholarly, cited scientists possess the formulation and process expertise to match polymer architecture, material and physical characteristics to meet the challenges facing the most demanding pharma applications. Available locally from SK Chemtrade, Ashland’s recent cellulosic excipients have been designed to solve the challenges met by formulators in matrix-controlled release formulations while meeting all compendials for these excipients.
HPC POLYMER FOR MODIFIED RELEASE APPLICATIONS
In pharmaceutical publications, hydroxypropyl cellulose (HPC) has long been the tablet binder of choice for oral solid dosage forms. Ashland’s klucel HPC provides a remarkable set of physical properties for tablet binding, modified release, film coating and hot melt extrusion. Low molecular weight grades provide unmatched, efficient tablet binding, as well as an adhesive and elastic tablet coating. Klucel can also be used in melt applications such as melt granulation and hot melt extrusion.
HPC Polymer for Modified Release Applications
In pharmaceutical publications, hydroxypropyl cellulose (HPC) has long been the tablet binder of choice for oral solid dosage forms. Ashland’s klucel HPC provides a remarkable set of physical properties for tablet binding, modified release, film coating and hot melt extrusion. Low molecular weight grades provide unmatched, efficient tablet binding, as well as an adhesive and elastic tablet coating. Klucel can also be used in melt applications such as melt granulation and hot melt extrusion.
In October 2022, Ashland introduced klucel xtend HPC controlled release matrix former, designed to deliver unsurpassed process versatility and release profile efficiency. In addition to expanding its controlled release portfolio, klucel xtend HPC is the latest addition to the klucel line. Until now, there were limited options for managing the release profile of formulations, especially high dose, controlled release formulations.
Ashland’s step change klucel xtend HPC has been shown to match the release profile of hypromellose controlled-release formulations at half the polymer concentration. The highly reduced polymer concentration offers the possibility of smaller tablets or higher dosage, if necessary. This new excipient presents unrivalled versatility across a broad range of APIs in every manufacturing process, such as dry granulation, wet-granulation, direct compression and holt-melt extrusion.
The need for hot-melt extrusion polymers is expected to grow as the pharma industry moves to implement more continuous and sustainable processes. According to Ashland, Klucel xtend HPC is the only cellulosic excipient that provides a compendial extended-release polymer option for plasticiser-free hot-melt extrusion.
OPTIMAL PERFORMANCE WITH IMPROVED HPMC CHARACTERISTICS
Hypromellose is the most widely used polymer in hydrophilic matrix systems with widespread use in controlled-release dosage forms. Ashland’s benecel HPMC is a versatile excipient with a variety of applications.
The latest addition to the benecel HPMC controlled release family is benecel xrf HPMC. It presents finer particles compared to other benecel grades, with consistent particle size and optimised polymer structure for optimal performance in large-scale, high speed tableting and the toughest tableting challenges. The features of benecel xrf provide better flowability and improved tablet strength and compatibility, while retaining a reliable controlled-release profile.
Improved Processability and Excellent Functionality
In today’s environment, pharmaceutical companies must get products to market faster to reduce costs. The fierce competition and expansion into emerging markets has resulted in increased demand for tablet ingredients with the best functionalities. Oral-dosage formulators are also looking for the finest ingredients to deliver desired tablet functionalities while meeting their production efficiency needs.
Ashland’s range of directly compressible (DC) benecel DC HPMC is surface modified, co-processed excipients delivering innovation and efficiency in the tablet-making process. These optimised excipients don’t compromise on the performance of the final product.
Typically, to manufacture a tablet that can control the release of the active ingredient, the ingredient powder must first be granulated to be compressed into the solid-dosage form. Benecel DC HPMC have been surface modified and co-processed, resulting in surface modification not enabled by direct blend. As a result, with benecel DC HPMC controlled- release matrix former, the ingredient mix can be directly compressed into the tablet. Improved benecel DC HPMC also help solve common challenges related to material processing including poor powder flow, powder adhesion to surfaces, segregation and electrostatic in pharmaceutical unit processes.
SK Chemtrade is a preferred distributor of Ashland Specialty Ingredients.
Article written by: Pharmaceutical & Cosmetic Review
