List of Excipients in Branded Drug GLYBURIDE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
TEVA Pharmaceuticals USA Inc	GLYBURIDE	glyburide	0093-9477	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
TEVA Pharmaceuticals USA Inc	GLYBURIDE	glyburide	0093-9477	CELLULOSE, MICROCRYSTALLINE
TEVA Pharmaceuticals USA Inc	GLYBURIDE	glyburide	0093-9477	MAGNESIUM PALMITOSTEARATE
TEVA Pharmaceuticals USA Inc	GLYBURIDE	glyburide	0093-9477	SODIUM ALGINATE
TEVA Pharmaceuticals USA Inc	GLYBURIDE	glyburide	0093-9477	TALC

Generic Drugs Containing GLYBURIDE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA, Inc.	glyburide	0093-8034	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA, Inc.	glyburide	0093-8034	MAGNESIUM STEARATE
Teva Pharmaceuticals USA, Inc.	glyburide	0093-8034	SILICON DIOXIDE
Teva Pharmaceuticals USA, Inc.	glyburide	0093-8034	SODIUM STARCH GLYCOLATE TYPE A POTATO
Teva Pharmaceuticals USA, Inc.	glyburide	0093-8034	STARCH, CORN

What are the Most Frequently-Used Excipients in GLYBURIDE?

# Of NDCs	Excipient
15	ALUMINUM OXIDE
2	CALCIUM CARBONATE
2	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
2	CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
89	CELLULOSE, MICROCRYSTALLINE

Excipient Strategy and Commercial Opportunities for Glyburide

Last updated: February 27, 2026

Glyburide, a second-generation sulfonylurea used in type 2 diabetes management, relies on specific excipients for formulation stability, bioavailability, and patient compliance. Optimizing excipient selection can enhance manufacturer competitiveness and expand market share.

What are the Key Excipient Strategies in Glyburide Formulations?

1. Enhancing Stability and Shelf Life
Glyburide's chemical stability depends on excipients that prevent degradation. Commonly used stabilizers include antioxidants like ascorbic acid and chelating agents that mitigate moisture and oxygen sensitivity.

2. Improving Bioavailability
Glyburide has variable absorption. Use of surfactants such as sodium lauryl sulfate (SLS) improves dissolution rate. Multiparticulate formulations with sodium starch glycolate or croscarmellose sodium accelerate disintegration.

3. Patient Compliance through Formulation Design
Preferences shift toward oral dispersible tablets and microgranules, which incorporate excipients like crospovidone for rapid disintegration, or taste-masking agents like flavorings and sweeteners to improve palatability.

4. Compatibility and Manufacturing Efficiency
Excipients must be compatible with glyburide's chemical structure and facilitate large-scale manufacturing. Direct compression excipients like microcrystalline cellulose are preferred for cost efficiency.

Commercially Relevant Excipients and Formulation Trends

Excipient Type	Purpose	Examples	Market Trend
Disintegrants	facilitate rapid breakdown	croscarmellose sodium, sodium starch glycolate	Preference for fast-dissolving tablets
Binder agents	ensure tablet integrity	povidone, pregelatinized starch	Widely used in multi-particulate systems
Surfactants	improve dissolution	SLS, polysorbates	Increasing as bioavailability focus intensifies
Fillers	volume and stability	microcrystalline cellulose, lactose	Cost-effective, compatible options

Commercial Opportunities in Excipient Innovation

1. Novel Disintegrants
Introducing super-disintegrants such as crospovidone variants can reduce disintegration time, appealing to immediate-release product markets.

2. Taste Masking Technologies
Developing advanced flavoring excipients enhances user acceptance, especially in pediatric or geriatric doses.

3. Excipient-Drug Compatibility Technologies
Innovating with excipients that stabilize glyburide's labile sites during manufacturing extends shelf life and reduces waste.

4. Differentiated Dosage Forms
Formulation of mouth-dispersible tablets or orally disintegrating films (ODFs) increases patient adherence and creates new market segments.

5. Custom Excipient Blends
Partnerships with excipient manufacturers for tailored blends optimize performance and manufacturing efficiency.

Market Landscape and Considerations

The global oral antidiabetic drug market is projected to reach USD 98.2 billion by 2027, with glyburide accounting for a sizable proportion due to its cost-effectiveness. Excipient suppliers can leverage this to develop innovative, patentable excipient systems.

Regulatory frameworks, such as the US FDA's guidelines for excipient safety and stability, influence formulation strategies. Companies must also consider regional preferences and patent landscapes for formulation components.

Regulatory and Manufacturing Standards

• U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines specify excipient safety and stability requirements.
• Excipients must be Generally Recognized as Safe (GRAS) or approved excipients with documented compatibility data.
• Quality control measures include batch testing for purity, particle size distribution, and excipient-drug interaction profiling.

Key Takeaways

• Excipient choices for glyburide focus on stability, bioavailability, patient compliance, and manufacturing efficiency.
• Trend shifts favor fast-dissolving and taste-masked formulations, presenting opportunities for innovation.
• Developing novel disintegrants and advanced delivery systems can differentiate products on market and extend patent exclusivity.
• Regulatory compliance and regional market preferences influence formulation strategies.
• The expanding global diabetic care market supports continued investment in excipient innovation.

FAQs

1. How do excipients influence glyburide's shelf life?
Excipients like antioxidants and moisture inhibitors slow degradation, extending shelf life and maintaining potency.

2. What are the main considerations when selecting excipients for glyburide?
Compatibility with glyburide, regulatory approval, stability, and manufacturability are primary factors.

3. Can excipient innovation create competitive advantages?
Yes. Advanced disintegrants, taste-masking agents, and delivery systems can improve patient adherence and differentiate products.

4. What are the dominant excipient types in glyburide formulations?
Disintegrants, binders, fillers, and surfactants are most common, with recent trends favoring fast-dissolving and palatable formats.

5. Are there patent opportunities in glyburide excipient systems?
Potential exists in novel excipient combinations, specialized delivery formats, and taste-masking technologies.

---

References

[1] Food and Drug Administration. (2021). Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. U.S. FDA.

[2] European Medicines Agency. (2017). Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning biotechnological/biological products.

[3] Market Research Future. (2021). Oral Antidiabetic Drugs Market Research Report.

[4] Sharma, S. et al. (2019). Advances in formulation of oral drug delivery systems for glyburide. International Journal of Pharmaceutics, 562, 71-83.