Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms
The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.

Pharmaceutical Technology


Figure 11
At a time when formulators are faced with increasing numbers of poorly soluble drugs, it has become very important to select superdisintegrants to maximize drug dissolution. A comprehensive study conducted to evaluate the effect of crospovidone, croscarmellose sodium, and sodium starch glycolate on the dissolution rates of poorly soluble drugs with varying aqueous solubility showed crospovidone Type B to provide the fastest rate of dissolution for poorly soluble drugs. The fact that tablet strength and disintegration times for the tablets containing each drug and all the superdisintegrant studies were similar showed that tablet hardness and disintegration did not influence dissolution. Crospovidone Type B has unique chemistry, particle size, and particle morphology that result in high interfacial activity, which significantly aids dissolution.


Figure 12
The authors wish to acknowledge the support and contributions of ISP's pharmaceutical research and development and analytical scientists in Hyderabad, India, and Wayne, New Jersey.

Jagdish Balasubramaniam is a manager of pharmaceutical research and development at International Specialty Products India, and Tim Bee* is a senior director of pharmaceuticals at International Specialty Products, 1361 Alps Rd., Wayne, NJ 07470, tel. 973.628.4148,

*To whom all correspondence should be addressed.


1. J.R. Johnson et al., "Effect of Formulation Solubility and Hygroscopicity on Disintegrant Efficiency in Tablets Prepared by Wet Granulation, in Terms of Dissolution," J. Pharm. Sci. 80 (5), 469–471 (1991).

2. J.K. Pandit, M.K. Tripathi, and R.J. Babu, "Effect of Tablet Disintegrants on the Dissolution Stability of Nalidixic Acid Tablets," Pharmazie 52 (7), 538–540 (1997).

3. A. Sakr, M. Bose, and A. Menon, "Comparative Effectiveness of Superdisintegrants on the Characteristics of Directly Compressed Triamterene Hydrochlorothiazide Tablets," Pharm. Ind. 55 (10), 953–957 (1993).

4. J. Balasubramaniam et al., "Effect of Superdisintegrants on Dissolution of Cationic Drugs," Dissolution Technologies 15 (2), 18–25 (2008).

5. USP 31–NF 26 (US Pharmacopeial Convention, Rockville, MD, 2008).

6. S.A. Qureshi, "Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interperatation," Dissolution Technologies 13 (4), 18–23 (2006).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here