Formulation and evaluation of press coated tablets of salbutamol sulphate for time controlled release
Main Article Content
Abstract
sulphate in order to attain a time controlled release for treatment of nocturnal asthma. The core was prepared by direct
compression, while press coating technique was used in coating the outer layer there by preparing a press coated tablet. The
immediate release core formulations comprised of salbutamol sulphate and disintegrants like crospovidone, croscarmellose
sodium and sodium starch glycolate in different ratios with the drug. The outer coat formulations were prepared using a
hydrophilic (HPMC) and hydrophobic (EC) polymer of similar viscosity. The polymers were reviewed individually for
their influence on lag time further obtaining the lag time using polymer combinations were assessed by employing central
composite design. All the preliminary trials were evaluated for various post compression parameters along with the dissolution
study that was performed using USP paddle method at 50 rpm in 0.1 N HCl and phosphate buffer pH 6.8. The formulation
containing 300 mg of EC N50 and 75‑100 mg of HPMC E50 may be regarded as the minimum quantity required in outer
press coat so as to attain a predetermined lag time of 6 h.
Key words: Central composite design, ethylcellulose, hydroxypropyl methylcellulose, press coat, salbutamol sulphate, time controlled release
Downloads
Article Details
This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.
References
Sangalli ME, Maroni A, Zema L, Busetti C, Giordano F, Gazzaniga A.
In vitro and in vivo evaluation of an oral system for time and/or
site‑specific drug delivery. J Control Release 2001;73:103‑10.
Sirkiä T, Mäkimartti M, Liukko‑Sipi S, Marvola M. Development
and biopharmaceutical evaluations of a new press‑coated
prolonged‑release salbutamol sulphate tablet in man. Eur J Pharm
Sci 1994;1:195‑201.
Swarbrick J. Encyclopedia of Pharmaceutical Technology. Vol. 1, 3rd ed.
Informa Healthcare USA: Taylor and Francis; 2007. p. 1287‑97.
Bussemer T, Otto I, Bodmeier R. Pulsatile drug‑delivery systems. Crit
Rev Ther Drug Carrier Syst 2001;18:433‑58.
Kalantzi LE, Karavas E, Koutris EX, Bikiaris DN. Recent advances in oral
pulsatile drug delivery. Recent Pat Drug Deliv Formul 2009;3:49‑63.
Pozzi F, Furlani P, Gazzaniga A, Davis SS, Wilding IR. The time
clock system: A new oral dosage form for fast and complete
release of drug after a predetermined lag time. J Control Release
;31:99‑108.
Cerea M, Zema L, Palugan L, Gazzaniga A. Recent developments in dry
coating. Pharm Technol Eur 2008;20:40‑4.
Fukui E, Miyamura N, Uemura K, Kobayashi M. Preparation of enteric
coated timed‑release press‑coated tablets and evaluation of their
function by in vitro and in vivo tests for colon targeting. Int J Pharm
;204:7‑15.
Lin SY, Kawashima Y. Current status and approaches to developing
press‑coated chronodelivery drug systems. J Control Release
;157:331‑53.
Svedmyr N, Simonsson BG. Drugs in the treatment of asthma. Pharmacol
Ther B 1978;3:397‑440.
Ministry of Health and Family Welfare. Government of India. Indian
Pharmacopoeia. Vol. 2. Ghaziabad: Indian Pharmacopoeia Commission;
p. 178, 182‑3.
Aulton ME. Pharmaceutics: The Science of Dosage form Design, 2nd ed.
London: Churchill Livingstone; 2007. p. 114‑36.
Qureshi J, Amir M, Ahuja A, Baboota S, Ali J. Chronomodulated drug
delivery system of salbutamol sulphate for the treatment of nocturnal
asthma. Indian J Pharm Sci 2008;70:351‑6.
Chaudhari S, Patil V. Formulation and optimization of
chronopharmaceutical drug delivery system and study effect of variables
by central composite design technique. J Pharm Res 2012;5:2987‑93.