Page 29 - 2021

Ph.D.
(Pharmacy)
DEVELOPMENT AND OPTIMIZATION OF DEXKETOPROFEN
TROMETAMOL MULTIPARTICULATES DOSAGE FORMS

Ph.D. Scholar : Patel Alpeshkumar Rameshbhai
Research Supervisor : Dr. B. G. Prajapati

Regi. No.: 16146021004
Abstract :
The aim was to prepare an extended release multi-particulates dosage form of
Dexketoprofen trometamol which is the pharmacologically active isomer of ketoprofen.
Utilization of active enantiomer with minimal dose and administration frequency,
extended release multi-particulates dosage form were explored. Drug loaded pellets were
prepared by two techniques i) Extrusion spheronization technique and ii) Wurster coating,
while extended release coating of these two different drug pellets were done by wurster
coating process.

For drug loaded pellets prepared by extrusion spheronization process, lactose and
microcrystalline cellulose as diluents, glycerin as plasticizer and povidone as binder were
selected while for wurster process microcrystalline cellulose spheres as inert core,
povidone as binder and Talc as anti-adherent were used. Kollicoat SR 30D as sustained
release polymer, triethyl citrate as plasticizer and Talc as anti-tacking agent were used
common for both drug loaded pellets coating for better comparison.

Results of various drug pellets formulation by extrusion spheronization process indicated
that binder concentration, plasticizer concentration and lactose to MCC ratio at level of
1.49 to 1.95, 0.99 to 1.37 and 0.95 to 1.85 respectively yield good drug loaded pellets with
targeted particle size fractions, assay and friability. Extruder and spheronizer speed were
required 50 and 100 rpm respectively as optimum processing condition. Trial results of
extended release coating of extrusion spheronised drug pellets were dictate that 28
%w/w extended release coating level with 10 %w/w talc concentration of total solid
material and 10.0% w/w tri-ethyl citrate with respect to dry polymer amount yielded
desired drug product quality attributes. Extended release coating process parameters
optimization study indicated that atomisation air pressure 1.0 to 1.2 bar, product bed
temperature 29 to 34°C and 7.8 to 10.0 gm/min yield good quality of extended release
coated pellets in terms of desired quality attributes i.e. with minimum amounts of fines
and agglomerates, drug release profile, efficiency. This designed space was confirmed by
taking confirmatory batches. Dose dumping study, multimedia dissolution and stability
study results were satisfactory for optimized formulation.
Results of various drug pellets formulation by fluid bed coating process indicated that 5%

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