Formulation and evaluation of domperidone pellets prepared by powder layering technology

Golam Kibria, Afsana Akhter, K M Ariful Islam

Abstract


The goal of the present study is to evaluate the influence of the formulation and operating conditions on pellet preparation by the pan technique.The effect of initial core weight on the physical parameters of pellets as well as to conduct stability study was also the goal of this study. For this domperidone maleate was selected as the model drug. Pellets were prepared by layering of powdered drug on sugar-based cores. Inert cores were intermittently treated with micronized drug powder and binding solution. This treatment led to the formation of multiple layers of drug particles around an inert core resulting in the production of pellets that can further be coated by different polymers to obtain modified release formulations. Scanning electron microscopy was employed to image the surface morphology of the prepared pellets. Drug loading efficiency, %
yield, size, and shape uniformity of pellets were increased along with increasing the initial core weight. Drug content and dissolution study were performed by following HPLC and UV–Visible method. About 50% and 80% drug was released
within 7.72 m and 13.66 m respectively in 0.1N HCl media (pH 1.2). Physical appearance of the prepared pellets, potency, moisture content, pellets size and shape, dissolution data, release rate constant, diffusion exponent (P<.05) over the stability period showed that the system is efficient for the production of highly stable formulations. This study also showed the good performance of the conventional coating pan system in obtaining instant release domperidone pellets prepared by the powder layering technique.


Full Text:

PDF

References


Walter GC. Conventional and specialized coating pans. Bristol-Mayers,

Evansville, Indiana. 1989.

Blythe RH. Sympathomimetic preparation. U.S. Patent. 2, 738,303. 1956

Armstrong NA. Tableting. In: Aulton ME, editor. Pharmaceutics: The

science of dosage form design. New York: Churchill Livingstone; 1997.

Flament MP, Leterme P, Gayot A, Gendrot E, Bruna E, Cousin G.

Development and industrial scale-up of tablets containing modified-

release pellets. Pharm Tech Eur 1994;2:19-25.

Laicher A, Lorck CA, Tobin J, Stanilaus F. Process optimization of pellet

coating and drying using fluid bed production units. Pharm Tech Eur

;8:41-8.

Andrew BC, Shargel L. Modified-release drug products and targeted drug delivery system. In: Applied biopharmaceutics and pharmacokinetics.

rd ed. USA: Appleton and Lange; 1941. p. 225-64.

Singh R, Poddar SS, Chivate A. Sintering of wax for controlling release

from pellets. AAPS PharmSciTech 2007;8:E1-9.

Sellassie IG, Gordon RH, Fawzi MB. Evaluation of a high-speed pelletization process and equipment. Drug Dev Ind Pharm 1985;11:1523-41.

. Ghebre-Shellasie I. Pellets: A general overview. In: Ghebre-Shellasie

I, editor. Pharmaceutical pelletization technology. New York: Marcel

Dekker Inc; 1989. p. 6-7.

Vervaet C, Baert L, Remon J. Extrusion spheronisation: A literature

review. Int J Pharm 1995;116:131-46.

Prabakaran L, Bajpai M. Novel micropelletization technique: Highly

improved dissolution, wettability and micromeritic behavior of

domperidone. Curr Drug Deliv 2006;3:307-13.

Janssen-Cilag Pty Ltd, Auckland, New Zealand. Data sheet of

MOTILIUMTM tablet. Available from: http://www.medsafe.govt.nz/Profs/

datasheet/m/motiliumtab.htm. [cited in 2006].

British Pharmacopoeia 2007: Dissolution study of domperidone tablet.

The stationery office; vol. 3. p. 2530-1.

Remington: The Science and Practise of Pharmacy. 21st ed. vol. 1. p. 921.

Thibert R, Hancock BC. Direct visualization superdisintegrant hydration

using environmental scanning electron microscopy. J Pharm Sci

;85:1255-8.

Yen SY, Chen CR, Lee MT, Chem LC. Investigation of dissolution

enhancement of nifedipine by deposition on superdisintegrants. Drug

Dev Ind Pharm 1997;23:313-7.

Iwata M, Ueda H. Dissolution properties of glibenclamide in combinations

with polyvinylpyrrolidone. Drug Dev Ind Phar 1996;22:1161-5.

Lu WG, Zhang Y, Xiong QM, Bao YC, Chen QH. Development of

nifedipine pellets with a high bioavailability. Chin Pharm J Zhongguo

Yaoxue Zazhi 1995;30:24-6.

Mockel JE, Lippold BC. Zero order release from hydrocolloid matrices.

Pharm Res 1993;10:1066-70.

Montgomery DC. Percentage points of F distribution. In: Design and

analysis of experiments. 5th ed. New York: John Wiley and Sons Inc.;

p. 646.




DOI: http://dx.doi.org/10.22377/ajp.v4i1.123

Refbacks

  • There are currently no refbacks.