Pharmatrans-SANAQ modified release solutions

Pharmatrans-SANAQ offers a range of highly developed neutral and functional starter pellets that can be used to achieve modified release of active pharma ingredient in various oral solid dosage (OSD) forms to meet different therapeutic needs.

These pellets can be applied to achieve both sustained (slow) release or extended (delayed) release of API, as well as fine-tuning dissolution profiles, targeting specific sites in the body, or in taste masking.

What is a sustained release tablet?

To answer the question ‘What is modified release?; the term (often abbreviated as MR) is used to describe oral solid dose (OSD) products where the formulation is tailored to delay or extend the release of the active ingredient into the body’s bloodstream. For this reason, MR formulations can also be called sustained release or slow release. Whatever the label, modified release drug delivery systems are developed to control the rate and/or the site of release of drugs to achieve specific clinical objectives that cannot be attained with conventional dosage forms. Modification of release profile can also assist patient compliance with dosage regime or improve convenience. As a technical consideration, MR formulations may protect drugs that are particularly sensitive to acids in the digestive system.

Sustained release vs extended release

While immediate release is often preferred to support ‘fast acting’ claims, modified release profiles can offer a number of therapeutic benefits, primarily in extended release or delayed release, where the modification can serve to control the levels of active ingredient in the patient bloodstream, serving to avoid or mitigate any identified adverse side-effects.

MR formulation may also be applied to prolonged release or extended release tablets, administered to heal certain parts or target body parts. Once they are introduced into the blood system they release the drug either on the specific part or near the target site that needed the cure; this is a key difference from normal sustained release formulations that work globally.

Achieving modified release

MR can be achieved in numerous ways, including capsules containing film coated pellets, tablets with functional coating films, or tablets considered as matrix to release drug with specific kinetic through controlled dissolution profile.

Pharmatrans offers excipients such as Sugar spheres, Mannitol spheres; Cellets and TAP suitable for MR in capsules or minitablets or MUPS and SR matrix suitable to formulate tablets.

Pellets can be classified as being neutral substrates or functional ingredients, and both can serve as carriers for subsequent drug layering to achieve modified release. While neutral bead type starter pellets are inert so as not to interact with the API but serve as carriers to be layered with API, functional starter pellets, in contrast, actively support the formulation by improving API solubility, dissolution, or stability.

Modified release solutions

Neutral bead starter pellets can be formed from various excipients and excipient combinations, including sugar, microcrystalline cellulose (MCC), polyols, carnauba wax, silica, or lactose combined with starch or cellulose.

Pharmatrans Sanaq’s Sugar Spheres SANAQ® are neutral beads made of sucrose and maize starch to form white almost spherical cores to be coated with API. This makes them ideal for sustained release tablet formulations demanding controlled release or in multi-particle capsules, sachets or tablets, where the neutral bead starter cores can be combined with different technologies for layering and coating.

Pharmatrans also offers Cellets^® as highly optimised MCC neutral pellets that have advantages over sugar pellets in supporting innovative drug delivery dosage formulations optimized for homogeneous distribution and controlled release, and also offer other benefits, including uniform spherical shape and structure, narrow particle size distribution within each fraction, compatibility with sensitive APIs, high abrasion resistance for superior coating, and higher payload permitting smaller capsule sizes.

Resources

Click on Wiki: Modified-release dosage for overview.
Click on Modified-Release Drug Products and Drug Devices for background reading.
Click on Modified-Release Formulations: Improving Efficacy and Patient Compliance for more on MR benefits.
Click on Sustained-release, extended-release, and other time-release formulations in neuropsychiatry for scientific study on mental health applications.
Click on Starter pellets: Materials, manufacturing methods, and applications for further information.
Click on Pharmatrans Sanaq TAP^® tartaric acid pellets  for product details.