title: Kozeny-Carman permeability relationship with disintegration process predicted from early dissolution profiles of immediate release tablets.
abstract: This study was oriented toward the disintegration profiling of the diclofenac sodium (DS) immediate-release (IR) tablets and development of its relationship with medium permeability kpermbased on Kozeny-Carman equation. Batches (L1-L9) of DS IR tablets with different porosities and specific surface area were prepared at different compression forces and evaluated for porosity, in vitro dissolution and particle-size analysis of the disintegrated mass. The kpermwas calculated from porosities and specific surface area, and disintegration profiles were predicted from the dissolution profiles of IR tablets by stripping/residual method. The disintegration profiles were subjected to exponential regression to find out the respective disintegration equations and rate constants kd. Batches L1 and L2 showed the fastest disintegration rates as evident from their bi-exponential equations while the rest of the batches L3-L9 exhibited the first order or mono-exponential disintegration kinetics. The 95% confidence interval (CI95%) revealed significant differences between kdvalues of different batches except L4 and L6. Similar results were also spotted for dissolution profiles of IR tablets by similarity (f2) test. The final relationship between kdand kpermwas found to be hyperbolic, signifying the initial effect of kpermon the disintegration rate. The results showed that disintegration profiling is possible because a relationship exists between kdand kperm. The later being relatable with porosity and specific surface area can be determined by nondestructive tests.
authors.affiliation: a College of Pharmacy , University of Health Sciences , Rohtak , India.
authors.forename: Parveen
authors.initials: P
authors.lastname: Kumari
authors.affiliation: a College of Pharmacy , University of Health Sciences , Rohtak , India.
authors.forename: Pooja
authors.initials: P
authors.lastname: Rathi
authors.affiliation: a College of Pharmacy , University of Health Sciences , Rohtak , India.
authors.forename: Virender
authors.initials: V
authors.lastname: Kumar
authors.affiliation: b PGIMS, University of Health Sciences , Rohtak , India.
authors.forename: Jatin
authors.initials: J
authors.lastname: Lal
authors.affiliation: c Department of Pharmaceutical Sciences , Maharshi Dayanand University , Rohtak , India.
authors.forename: Harmeet
authors.initials: H
authors.lastname: Kaur
authors.affiliation: a College of Pharmacy , University of Health Sciences , Rohtak , India.
authors.forename: Jasbir
authors.initials: J
authors.lastname: Singh
mesh_terms: D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D007700:Kinetics; D010539:Permeability; D016062:Porosity; D012995:Solubility; D013607:Tablets
chemical_list: D005079:Excipients; D013607:Tablets
keywords: Disintegration rate; dissolution; in-vitro models; particle size; permeability; porosity; pre-blend; solid dosage form; tableting