Thesis

The Effect of Hypromellose Type and Concentration on Drug Release and Layering Process of Sitagliptin Layer in an Anti-diabetic Fixed-Dose Combination Tablet

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Diabetes mellitus (DM) is a metabolic disease where insulin production and/or action is defective,
leading to a chronic high blood sugar level (hyperglycemia), in which the highest type is type 2
diabetes mellitus (T2DM). Some of the pharmacological treatments are metformin and sitagliptin
where the combination treatment of them provides more effects compared to the monotherapy. An
imported drug called Janumet XR contains this combination treatment, which includes
extended-release metformin as the core and immediate-release sitagliptin as the synergistic layer. To
make a coated tablet, polymer is important to control the drug release. HPMC is used as the polymer
in the coating layer, in which its performances are influenced by several factors, including viscosity
grade and concentration. Thus, this experiment is aimed to study the effect of HPMC viscosity grade
and concentration towards the drug release and layering process of sitagliptin layer in an anti-diabetic
fixed-dose combination drug, namely sitagliptin-metformin extended-release tablet. This was done by
first making the metformin core tablet, followed by coating it with sitagliptin layer, and evaluating the
sitagliptin layer through several evaluation parameters, including viscosity of coating solution; coating
processes; tablet appearance, weight, thickness, and disintegration time; and the dissolution profile.
According to the experiment, it is found that HPMC viscosity grade and concentration may have
effects towards these parameters, where higher concentration and viscosity grade resulting in higher
evaluation parameters, longer disintegration time and dissolution rate, and smoother surface,
although most of the effects are insignificant.

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Detail Information

Series Title

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Call Number

PHA 24-002

Publisher

i3L, Jakarta : i3L, Jakarta., 2024

Collation

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Language

English

ISBN/ISSN

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Classification

NONE

Content Type

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Media Type

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Carrier Type

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Edition

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Subject(s)

concentration
sitagliptin
hypromellose (HPMC)
viscosity grade
evaluation parametersevaluation parameters

Specific Detail Info

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Statement of Responsibility

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