E-drug: Registration Requirement for Combination Products of
There have been combination products of INAH, rifampicine, pyrazinamide
(all in one tablet) submitted for registration. As these were well
knowndrugs and logical combinations so they have been registered in Sri
Lanka on the standard pharmaceutical criteria of dissolution etc.
Recently a chest physician has brought to our notice publications in 1986
and 1989 which show opposite effects on these combinations. That is, in
one publication the combining of these drugs did not affect the
bio-availability whereas in another publication it did. The references to
the publications are given at the end of this letter. *
Could anybody who has experience with this problem please let us know
whether bio-availability studies are required before registration of this
type of combination products.
*Cavenghi R, Aspesi F, Accella G, et al. Quality control of anti
tuberculosis drugs. Bull Int Union Tuberc Lung Dis1989; 64: 36-42.
*Ellard GA, Ellard DR, Allen BW, The bio-availability of isoniazid,
rifampicin and pyrazinamide in two commercially available combined
formulations designed for use in short course treatment of tuberculosis.
Am Re Respir Dis 1986; 133: 1076-1080.
Dr K Weerasuriya
Department of Pharmacology
Faculty of Medicine
University of Colombo
P O Box 271
Colombo, SRI LANKA
phone/fax +94 1 695230
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