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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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yCD/HPyCD mixtures as solubilizer: solid-state characterization and sample dexamethasone eye drop suspension.

Phatsawee Jansook¹, Garnpimol C Ritthidej, Haruhisa Ueda

¹Faculty of Pharmaceutical Sciences, University of Iceland, Hofsvallagata 53, IS-107 Reykjavik, Iceland.

Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques

|November 25, 2010

Summary

Dexamethasone complexation with gamma-cyclodextrin (γCD) and 2-hydroxypropyl-γ-cyclodextrin (HPγCD) enhances dissolution and drug delivery through membranes. The synergistic effect of combined CDs allows control over drug release rates for improved eye drop formulations.

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles

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Published on: August 28, 2015

Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Materials Science

Background:

Dexamethasone is a corticosteroid used for its anti-inflammatory properties.
Cyclodextrins (CDs) are widely used to improve drug solubility and bioavailability.
Developing effective ocular drug delivery systems, particularly for scleral penetration, remains a challenge.

Purpose of the Study:

To investigate the complexation of dexamethasone with gamma-cyclodextrin (γCD) and 2-hydroxypropyl-γ-cyclodextrin (HPγCD).
To characterize solid dexamethasone/CD complexes and develop aqueous dexamethasone eye drop suspensions.
To evaluate the potential for enhanced drug delivery through the sclera.

Main Methods:

Solid complex systems (dexamethasone/CD) were prepared and characterized using FT-IR, DSC, and XRD.
In vitro drug dissolution testing was performed on the solid complexes.
Eye drop suspensions were formulated using γCD/HPγCD mixtures, P407, and PVP, followed by physicochemical characterization and permeation studies.

Main Results:

Solid complex formation was confirmed by characterization techniques.
Dexamethasone/γCD/HPγCD complexes exhibited significantly faster dissolution and release rates compared to individual CD complexes.
Eye drop suspensions showed particle sizes <10 μm, and HPγCD enhanced drug transport, though overall permeation decreased due to aggregate size.

Conclusions:

The combination of γCD and HPγCD demonstrated a synergistic effect, enhancing dexamethasone solubility and dissolution.
This synergistic complexation improved drug delivery through membrane barriers.
The γCD:HPγCD ratio in solid complexes can be adjusted to control dexamethasone release rates.