quality evaluation of finasteride manipulated capsules

QUALITY EVALUATION OF FINASTERIDE MANIPULATED CAPSULES:
THE IMPORTANCE OF EXCIPIENTS STANDARDIZATION
SANTOS, O.M.M1, SANTOS, A.L.A.,1 BONFILIO, R.,2 ARAÚJO, M.B. de1,
1
Faculdade de Ciências Farmacêuticas da Universidade Federal de Alfenas, Alfenas-MG, Brazil.
Departamento de Fármacos e Medicamentos, Universidade Estadual Paulista, Araraquara, SP, Brazil. Email: [email protected].
2
Dissolution profile, finasteride, capsules, physico-chemical analysis.
1. Introduction
The quality control analyses performed on products
manipulated in pharmacies is extremely important
to ensure physical and chemical quality of these
products, which will guarantee efficiency, safety
and credibility. Finasteride (FNS) is a drug used for
the treatment of benign prostatic hyperplasia and
androgenetic alopecia and it is widely prescribed in
Brazil in capsules form. The objective of this work
is to evaluate the physico-chemical quality of
finasteride capsules in order to check the need for
standardization
of
excipients
used
in
the
manipulation process.
2. Methods
The pharmaceuticals used were Proscar® 5 mg
tablets and three different products in capsules,
which were coded as product A, product B and
product C. The samples were analyzed by tests of
average weight, disintegration time, finasteride
content, content uniformity test and dissolution test.
3. Results
Only the product C showed dissolution profile similar
to the reference product in 30 minutes (Figure 1).
Table 1. Physico-chemical test results of tested products
Test
Results a
Proscar Product
Product Product
5mg
A
B
C
Average
Aproved Aproved Aproved Aproved
weight (mg)
Disintegra3
3
2
2
tion time
minutes minutes
minutes minutes
Finasteride
98.8
95.8
95.9
97.7
content (%)
Content
Aproved Aproved Aproved Aproved
uniformity
(%)
Dissolution Aproved Reproved Reproved Aproved
test (%)
a
U.S.P1 requirements: average weight (mg): ± 10.0%; disintegration
time: 45 min; finasteride content: 95.0 to 105.0%; content
uniformity: 85.0 to 115.0%; dissolution test: each unit ≥ 85.0%.
Table 2. Excipients used in tested products
Proscar®
Product
Product
A
B
Lactose, starch,
Lauryl
Starch
yellow ferric
sodium
and talc
oxide, docusate
sulphate
sodium, cellulose,
(0.5%),
talc, Mg stearate,
lactose,
Cellulose methyl
talc,
hydroxypropyl,
starch
titanium dioxide.
and
aerosil
Product
C
Lauryl
sodium
sulphate
(1.5%),
Mg
stearate,
aerosil,
talc and
starch
4. Conclusion
Although the products A and B presented appropriate
drug contents, these products failed the dissolution test.
These results indicated that the excipients interfering with
the in vitro release of finasteride, which highlights a need
for excipients standardization.
Acknowledgments
To N.C.Q./UNIFAL-MG.
Figure 1. Dissolution profiles of Proscar® 5 mg,
product A, product B and product C.
1
UNITED STATES PHARMACOPEIA, 32. ed. The United
States Pharmacopeial Convention, Rockville, MD, 2009.