A consistent dissolution profile is critical to deliver medications’ active ingredients. For that, disintegrant or superdisintegrant may be used in the formula. They will act through different mechanisms to provide fast disintegration and allow quick API dissolution.
PART I: Disintegration mechanisms
Disintegration is achieved through three main mechanisms, and your products’ specific disintegration will involve each of the three mechanisms to a different extent.
Material will draw in water, establishing a capillary network for liquid to penetrate within the tablet.
Water will then produce disintegrant swelling and dissolution of soluble particles.
Material swells with water upon contact, exerting pressure within tablet that overcomes tablet cohesiveness.
Material within tablet is deformed during compression step, but once disintegrant interacts with water, material is prone to recover initial shape and volume.
PART II: Roquette Disintegrant and Superdisintegrant solutions
A consistent disintegration and dissolution profile is critical for the delivery of your medications’ active ingredients.
Roquette understands this, and offers an extensive range of disintegrant and superdisintegrant solutions designed to fit your needs in a variety of formulation, manufacturing process and dosage forms.
We don’t just provide more disintegrant solutions than anyone else – we also offer peace of mind through product traceability from extraction of raw materials to final product.
For disintegration, no one size fits all
Our wide range of disintegrant offerings reflects our customers’ diverse formulation challenges. As no two formulations are the same, no one disintegrant or superdisintegrant is suited to maximize performance for every formulation.
The ionic nature of disintegrants/superdisintegrants might influence the dissolution of APIs. Non-ionic disintegrants prevent the formation of salts that could modify drug solubility and dissolution profile. Therefore, we offer both ionic and non-ionic products to meet your formulation and process needs.
Our non-ionic disintegrants include a selection of native starches, enabling customization potential due to their varied particle size and moisture capacity options. Co-processed with lactose (StarLac®) or mannitol (PEARLITOL® Flash), native starches provide high efficacy and robustness to your formulation.
Our superdisintegrant offerings meet the requirements necessary to achieve fast and robust disintegration with minimal amount of disintegrating agent. These properties facilitate the use of any ingredient you need in order to optimize other parameters of your formulation (compactability or drug solubility for example).
GLYCOLYS®, one of our sodium starch glycolate (SSG)-based products, offers solutions to specific environments and conditions susceptible to affect disintegrant performance as well as ensuring stability for drugs, like GLYCOLYS® Low pH ensures stability to acidic molecules.
GLYCOLYS® LV is designed to withstand stresses involved in high shear granulation processes, while maintaining the effective disintegration properties of sodium starch glycolate
GLYCOLYS® Low Solvent bolsters our SSG superdisintegrant portfolio. GLYCOLYS® Low Solvent brings even higher stability owing to its low ethanol content.
SOLUTAB® is composed of croscarmellose sodium, an insoluble hydrophilic polymer. The polymers’ structure facilitates both capillary wicking and swelling to achieve disintegration, as its long fibers increase the water spreading within the tablet structure, leading to swelling and the rapid breakdown of formulations.
|Native Starches||GLYCOLYS® range (Sodium Starch Glycolate)||SOLUTAB® (Croscarmelose Sodium)|
|Botanical origin||Maize, wheat, potato, pea||Potato||Wood, cotton|
|Water content||5-18% max||10% max||6-10% max|
|pH||Slightly acidic||Neutral or Acidic||Neutral or Acidic|
|Ethanol||0%||6% max||0.5% max|
|Primary mechanism||Swelling||Swelling||Wicking, Swelling|
|Suggested usage (wt %)||3-15.0%||2-8.0%||0.5-5.0%|
*Specific grade available that is not shear sensitive
It must not be forgotten that the composition of the tablet (filler, filler/binder, diluent) will also influence the disintegration performance of the disintegrant/superdisintegrant.