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Oral Hypoglycemic Agents: α-Glucosidase Inhibitors01:19

Oral Hypoglycemic Agents: α-Glucosidase Inhibitors

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α-glucosidase inhibitors, including acarbose (Precose), miglitol (Glyset), and voglibose (Voglib) (primarily available in Asia), are drugs that control blood sugar levels by delaying the digestion of starch and disaccharides. They achieve this by inhibiting α-glucosidase enzymes in the intestine, which slow the absorption of carbohydrates in the intestine, which in turn leads to a prolonged release of the glucoregulatory hormone GLP-1 from intestinal L-cells.
Acarbose and miglitol are...
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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Dipeptidyl Peptidase 4 Inhibitors01:23

Dipeptidyl Peptidase 4 Inhibitors

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Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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Drug Biotransformation: Overview01:16

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Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Related Experiment Video

Updated: May 30, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Long-Term Stabilized and Highly Soluble Bezafibrate-Gliclazide Co-Amorphous Binary System.

Jorge Cruz-Angeles1, Luz María Martínez2, Alice M López López1

  • 1School of Engineering and Sciences, Tecnologico de Monterrey, Campus Monterrey, Ave. Eugenio Garza Sada 2501 Sur, C.P. 64849, Monterrey, N.L., Mexico.

AAPS Pharmscitech
|January 30, 2025
PubMed
Summary

This study developed a co-amorphous formulation of Bezafibrate and Gliclazide to improve drug solubility for metabolic syndrome treatment. The new formulation significantly enhanced solubility and demonstrated long-term stability.

Keywords:
bezafibrateco-amorphousdiabetesdrug-druggliclazidehypercholesterolemiahyperglycemiametabolic syndrome

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Medicinal Chemistry

Background:

  • Metabolic syndrome (MS) affects a quarter of the global population, characterized by dyslipidemia, hypertension, and insulin resistance.
  • Poor solubility of existing drugs limits their efficacy in treating MS, necessitating novel formulation strategies.
  • Amorphous drug formulations can significantly enhance solubility and bioavailability.

Purpose of the Study:

  • To develop a novel co-amorphous (CoA) formulation combining Bezafibrate (BZT), a lipid-regulator, and Gliclazide (GZD), a hypoglycemic agent.
  • To investigate the solubility enhancement and long-term stability of the BZT-GZD co-amorphous system for potential simultaneous treatment of MS conditions.
  • To characterize the intermolecular interactions and thermal properties of the binary co-amorphous system.

Main Methods:

  • Construction of a phase diagram to analyze thermal properties and glass transition temperatures.
  • Fourier-transform infrared spectroscopy (FTIR) to identify intermolecular interactions (e.g., hydrogen bonds).
  • X-ray diffraction (XRD) and differential scanning calorimetry (DSC) to assess structural stability and amorphous state retention.
  • Solubility studies to quantify the enhancement of BZT and GZD solubility.

Main Results:

  • FTIR analysis confirmed intermolecular interactions, indicated by redshifts in IR bands.
  • Co-amorphous formulations significantly increased the solubility of both BZT (up to 4x) and GZD (up to 1.5x).
  • XRD and DSC confirmed the amorphous state was retained for over eight years, indicating excellent long-term stability.

Conclusions:

  • The developed BZT-GZD co-amorphous system demonstrates enhanced solubility and remarkable long-term physical stability.
  • This co-amorphous formulation presents a promising strategy for the simultaneous treatment of lipid dysregulation and hyperglycemia in metabolic syndrome.
  • The findings highlight the potential of co-amorphous drug combinations to overcome solubility challenges in treating complex diseases like metabolic syndrome.