Pharmatrans SANAQ® Sugar Spheres and MCC pellet excipients for controlled release

Recent trends have emphasised that multi-particulate drug delivery systems are especially suitable for achieving controlled or delayed release oral formulations with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.

Many multiparticulate products are based on an inert core that can take the form of sugar spheres or neutral microcrystalline cellulose (MCC) starter pellets. Pharmatrans SANAQ meets both needs with its range of Sugar Spheres and MCC Cellets.

Uses of sugar spheres

Sugar spheres have been used in the pharmaceutical industry since the 1960s as a carrier pellets that can be coated with active substance and sustained release additives. The product comprises sucrose (maximum of 92 percent), and is made into spheres by layering a sugar crystal with a sucrose-starch syrup or by applying a powder within a coating pan.

Since the sugar core contains no active substance itself, sugar spheres are an ideal platform for low-dose formulations or substances with a high effect/dose relation. Ideally, sugar spheres should combine high mechanical stability, resistance to attrition, low friability, highly uniform particle size distribution, high sphericity, a non-porous and smooth surface and outstanding microbiological quality.

What is microcrystalline cellulose?

Microcrystalline cellulose (MCC) is an inert material derived from refined wood pulp that can be used in pharmaceuticals, cosmetics and food production as a texturizer, anti-caking agent, fat substitute, emulsifier, extender, and bulking agent.

MCC is a naturally occurring polymer, composed of glucose units connected by a 1-4 beta glycosidic bond in linear cellulose chains bundled together as microfibril that exhibit high degrees of three-dimensional internal bonding resulting in a crystalline structure that is insoluble in water and resistant to reagents.

Sugar Spheres SANAQ^® neutral pellets

Sugar Spheres SANAQ® are neutral pellets made of Sucrose and maize starch that meet standards defined in the USP40-NF35, Ph. Eur and JP pharmacopoeia monographies for “Sugar Spheres”.

Sugar Spheres SANAQ® are designed for the production of dry dosage forms, with white almost spherical cores with slight sweet taste that can be used as a neutral basis for the production of pellets loaded with active pharmaceutical ingredient (API). Microcrystalline uses in tablets include formulations with a controlled release of the active substance (sustained release).

The multiparticular system is ideal for filling for capsules, sachets or tablets, where the neutral starter cores can be combined with different technologies for layering and coating.

Sugar Spheres SANAQ® are available in a range of 11 different types, with particle size distribution (PSD) ranging from 212-300 µm to 1,000-1,180 µm.

Other specifications tested to Ph. Eur/USP standards include physical parameters such as friability, sucrose and starch content, loss on drying, and sulphate ash. Tested microbiological parameters include total aerobic count, molds and yeasts proportion, long with freedom from E. coli, and salmonella.

Microcellulose CELLETS^® – Microcristalline Cellulose Pellets

Pharmatrans SANAQ® offers CELLETS® as highly optimised Microcristalline Cellulose (MCC) pellets as perfect tools for combinatory and controlled release products, supporting multiple dosage and retard  formulations optimized for homogeneous distribution and controlled release, as defined by the monographs of European and US pharmacopeias.

Two fundamental advantages of the MCC-based multiple dosage form are homogeneous distribution of the active agent and the controlled release of active ingredients.

CELLETS® are made under GMP conditions, exclusively using MCC material from certified suppliers and in line with monographs for Microcrystalline Cellulose (Ph. Eur., USP-NF).

Pharmatrans SANAQ® can supply CELLETS in uniform spherical shape and structure particle sizes ranging from 100 µm to 1000 -1180 µm. Across the range, they deliver powerful user benefits including superior formulation of sensitive actives due to the inertness of microcellulose MCC, high abrasion resistance for superior coating process, excellent compactibility due to high plasticity and higher payload permitting smaller capsule sizes.

Apart from product quality, wider benefits include highly responsive Pharmatrans SANAQ® customer service and support, including expert technical consultation in formulation design and problem-solving.

Resources

Click on Pharmatrans Sugar Spheres SANAQ® for more information.
Click on Pharmatrans Sanaq CELLETS® Microcristalline Cellulose Pellets for more information.
Click on Starter pellets: Materials, manufacturing methods, and applications to download overview of multiparticulate approaches.