Thesis

Formulation and Optimization of PEG-PG Eyedrop Product Emphasizing on Quality by Design (QbD) Approach

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Dry Eye Disease (DED) presents a significant challenge in ophthalmic care, necessitating effective
preservative-free eye drop formulations. This study investigates the influence of process variables and
polymer types, namely Hydroxypropyl Methylcellulose (HPMC) and Xanthan Gum, on critical quality
attributes (CQAs) of Polyethylene Glycol-Propylene Glycol (PEG-PG) eye drops, emphasizing a Quality
by Design (QbD) approach. Through a series of experiments, the physical properties of these
formulations, including pH, viscosity, osmolality, and density, were examined under initial and stress
(ST) conditions. Statistical analyses, encompassing unpaired t-tests and ANOVA, were conducted to
compare the formulations. Results indicate that both HPMC and Xanthan Gum maintain acceptable
clarity and color, with HPMC demonstrating greater robustness despite pH instability under ST
conditions. Xanthan Gum, at lower concentrations, exhibits elevated viscosity, posing formulation
challenges. However, statistical analyses reveal no significant differences between formulations in pH,
osmolality, and density under varied conditions. HPMC emerges as the preferred choice over Xanthan
Gum due to its superior performance. Recommendations for further optimization of process
parameters and exploration of alternative filtration methods are proposed to enhance formulation
stability and efficacy in treating DED.

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Availability

Detail Information

Series Title

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Call Number

PHA 24-003

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)

HPMC
Dry Eye Disease
preservative-free eye drops
formulation optimization
Xanthan

Specific Detail Info

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Statement of Responsibility

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