By Pharmatrans SANAQ…
Pharmatrans specific functional starter cores for improved bioavailability and dissolution
Pharmatrans Sanaq specialized range of pharmaceutical excipients and novel drug vehicles includes pellets to aid design of various types of solid dosage forms.
The range has been extended from standard types of microcrystalline cellulose, such as neutral starter cores CELLETS®, purely made of microcrystalline cellulose to Mannitol SANAQ Spheres (70% Mannitol pellets) to Tartaric acid pellet (TAP) providing a highly optimized functional starter core consisting of 100% tartaric acid.
Tartaric Acid
For the pharma industry, the main use of tartaric acid has been as a nontoxic and nonirritant material that can be incorporated into pharmaceutical formulations with bicarbonates, as the acid component of effervescent granules, powders and tablets.
Tartaric acid pellets used as functional starter cores provide a suitably acidic environment to encourage more rapid dissolution of high pH APIs.
Tartaric acid is also used in beverages, confectionery, food products and pharmaceutical formulations in three different ways:
- as an acidulant
- as a sequestering agent
- as an antioxidant synergist
TAP functional starter cores
TAP provides a new gold standard for formulator designers working with drugs that showing pH dependent solubility and therefore require an acidic environment to improve solubility, release, and absorption. The TAP core pellets can do a great job of creating the acidic microenvironment required to make their drug successful.
Pharmatrans Sanaq’s TAP® pharma particles are formulated for superior coating and layering properties for more reproducible product characteristics and to improve the dissolution profile In extended release tartaric pellet formulations.
The spherical TAP core acts as a functional starter that can be layered with the API drug substance, with subsequent polymer film coating to achieve extended release profile.
The main function of the tartaric acid TAP core is to act as a pH-lowering agent to suit drugs that have low solubility at higher pH-values. In particular, poorly soluble drugs in intestinal fluids at higher pH-values may induce a poor bioavailability as a significant problem. Such drugs include dabigatran, dypiridamol, and verapamil.
In these cases, the tartaric TAP core can enhance the drug release, speed dissolution and improve bioavailability.
TAP® advantages
Pharmatrans Sanaq TAP® Tartaric Acid Pellets are formed from particles that are highly optimised to support coating and layering processes to achieve reproducible product characteristics.
In extended release pellet formulations TAP® pharma tartaric acid starter cores can be integrated to reduce the pH-dependency of the drug release and therefore achieve the desired dissolution profile.
TAP pellets conform with current Ph. Eur / USP standards and are available in two different formats:
- TAP 200 (100µm-350µm particle size)
- TAP 400 (300µm-500µm particle size)
Resources
Click on Pharmatrans Sanaq TAP® Tartaric Acid Pellets for more information.