Once a Day Pellets of Theophylline by Extrusion Spheronization Technique Using Gelucire® Matrix

Autores

  • Satishkumar Jain Jain
  • Dr. Purnima Amin

Palavras-chave:

Theophylline, Once a day pellets, Extrusion spheronisation, Gelucire® 50/13, Gelucire® 50/02, Gelucire® 43/01.

Resumo

Theophylline, a xanthine bronchodilator has narrow therapeutic index (5 – 15 µg/mL). The aim of the present work was to prepare once a day pellets of theophylline containing at least 75% of the drug by extrusion spheronisation technique. Theophylline has good aqueous solubility of about 10 mg/mL in purified water at 37 ºC. Various grades of Gelucire® were used as release retardant. The developed formulations met the in vitro release profile as per USP 30 specifications. Interestingly addition of oil helped in retarding initial burst as well as in stabilising Gelucire® matrix from the aging effects which was confirmed by varying the concentration of the oil. The stabilisation of the formulation against aging was confirmed by DSC and in vitro release studies of the fresh and the aged samples. The developed pellets were evaluated for size, spherecity, drug content, flow rate, bulk density, tap density and in vitro release studies as per USP 30. The optimum formulation was with Gelucire® 43/01 and Avicel® CL611. 

Downloads

Publicado

2011-08-18

Edição

Vol. 2 N.º 1 (2011)

Secção

Research Articles

Licença

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

·         I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.

·         I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).

·         I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.

·          I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

_______________

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.