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{TANDF_FPP}CMO/CMO_A_365060(NEW).3d (CMO) [First Proof]
Current Medical Research and OpinionC213 Volume 25, Number 2 2008
0300-7995 Article 4784/365060
doi:10.1185/03007990802648903 All rights reserved: reproduction in whole or part not permitted
Brief report
In vitro disintegration studies of weekly
generic alendronate sodium tablets (70mg)
available in the US
,
Richard J. Dansereaui
ABSTRACT
Debbie J. Craili
Procter and Gamble Pharmaceuticals, Mason,
Background:
OH, USA
Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic
alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the
Alan C. Perkinsii
pharmaceutical attributes of the various generic formulations my affect the potential for local irritation
University of Nottingham, Nottingham, UK
and tolerability.
Address for correspondence: Scope:
Richard J. Dansereau, Procter and Gamble
The in vitro disintegration times were determined
ed users can download
using the method described in the US Pharmacopeia 30
Pharmaceuticals, Inc., 8700 Mason-Montgomery
(USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States
Road, Mason, OH 45040 USA. Tel.: þ1 513 622
was compared to that of the branded product.
1926; Fax: þ1 513 945 2995;
dansereau.rj@pg.com
thoris
le copy for personal use
Findings:
Key words:
The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr
Alendronate sodium tablets – Disintegration time –
lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax
C213
) was 53 s. The
United States copies/generics
three Barr lots and one Teva
n
t a sing
lot had rapid disintegration times which were similar to the disintegration
Accepted: 26 November 2009; published online: 23 December 2008
standards (530 s) for orally disintegrating tablets. Since there is no established disintegration time for
alendronate sodium tablets there can be no assurance that the generic tablets are equivalent to the branded
product in terms of esophageal exposure. However, the in vitro disintegration times have not been correlated
Copyright © 2009 Informa UK Limited
with in vivo disintegration performance.
Conclusions:
Not for Sale or Commercial Distribution
Copies of generic alendronate sodium tablets are approved based on the results of single-dose
bioavailability studies in healthy subjects and this is not considered adequate to establish similar
Unauthorized use prohibited. Au
display, view and pri
disintegration characteristics.
Introduction
Alendronate sodium is a bisphosphonate that has been evaluated in clinical
trails for up to 10 years and is approved worldwide for the treatment of post-
menopausal osteoporosis
1–3
.
Clinically, there have been reports of gastrointestinal adverse events includ-
ing dysphagia, esophagitis and ulceration of the stomach and esophagus asso-
ciated with oral bisphosphonate therapy
4,5
. In most cases, the esophageal
problemsfitthepatternofpill-inducedesophagitisorrefluxofpartiallydissolved
tablets from the stomach. The administration of oral forms of alendronate is
contraindicated inpatients withesophageal abnormalities thatdelay esophageal
emptying.
!
2009 Informa UK Ltd
www.cmrojournal.com In vitro disintegration studies of weekly generic alendronate sodium Dansereau et al.
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