List of Excipients in Branded Drug FLUCONAZOLE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Unit Dose Services	FLUCONAZOLE	fluconazole	50436-5128	ALUMINUM OXIDE
Unit Dose Services	FLUCONAZOLE	fluconazole	50436-5128	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
Unit Dose Services	FLUCONAZOLE	fluconazole	50436-5128	CELLULOSE, MICROCRYSTALLINE
Unit Dose Services	FLUCONAZOLE	fluconazole	50436-5128	CROSCARMELLOSE SODIUM

Generic Drugs Containing FLUCONAZOLE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	fluconazole	0054-0002	ANHYDROUS CITRIC ACID
Hikma Pharmaceuticals USA Inc	fluconazole	0054-0002	ORANGE
Hikma Pharmaceuticals USA Inc	fluconazole	0054-0002	SILICON DIOXIDE
Hikma Pharmaceuticals USA Inc	fluconazole	0054-0002	SODIUM BENZOATE

What are the Most Frequently-Used Excipients in FLUCONAZOLE?

# Of NDCs	Excipient
52	ALUMINUM OXIDE
7	ANHYDROUS CITRIC ACID
167	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
11	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Excipient Strategy and Commercial Opportunities for Fluconazole

Last updated: February 25, 2026

What are the key excipient considerations for fluconazole formulations?

Fluconazole is available in oral and injectable forms. Excipients influence stability, bioavailability, and patient compliance. The formulation's success hinges on selecting appropriate excipients.

Oral Formulation Excipients

• Fillers and Binders: Microcrystalline cellulose, lactose monohydrate improve tablet integrity.
• Disintegrants: Croscarmellose sodium facilitates tablet breakup.
• Coatings: Hydroxypropyl methylcellulose (HPMC) enhances stability and swallowability.
• Flavoring agents: Mint or raspberry flavor for patient acceptability.

Injectable Formulation Excipients

• Solvents: Purified water as the primary solvent.
• Stabilizers: Ethanol or benzyl alcohol to prevent microbial growth.
• pH adjusters: Citric acid or sodium hydroxide optimize pH for stability.

Functionality and Stability

Excipients must uphold chemical stability in storage, prevent drug degradation, and ensure consistent dosing. Stability data indicate that certain excipients, like lactose, may influence shelf life, especially in moisture-sensitive formulations.

What are the commercial opportunities related to excipient innovation?

Innovation in excipients can create differentiation, extend patent life, and reduce manufacturing costs. Opportunities include:

Developing Novel Excipients

• Taste-masked excipients: Coatings that mask bitterness for pediatric formulations.
• Enhanced disintegrants: Superdisintegrants that allow for smaller tablet sizes.
• Bioavailability enhancers: Excipients that improve solubility, such as Cyclodextrins, for rapidly dissolving formulations.

Formulation Advances

• Oral thin films: With flexible excipients, yielding improved patient compliance.
• Injectable suspensions or emulsions: Employing stabilizers that extend shelf life and compatibility with various storage conditions.

Regulatory and Cost Benefits

• Excipients approved globally, like HPMC and microcrystalline cellulose, accelerate regulatory pathways.
• Reducing excipient costs by sourcing from larger suppliers or developing bulk blends enhances margins.

Market Expansion

• Pediatric formulations with taste-masking and easy administration.
• Fungal infection treatments targeting immunocompromised populations, requiring specialized excipient profiles to boost stability and bioavailability.

How do excipient choices differ across regions?

Regulatory agencies impose varying requirements. FDA (U.S.) emphasizes excipient safety, stability testing, and clear labeling. EMA (Europe) mandates specific excipient disclosures, especially for allergens like lactose. Asian markets may favor cost-effective excipients with robust manufacturing footprints.

What are the competitive implications for pharmaceutical companies?

• Companies investing in innovative excipients can develop differentiated products, extending patent exclusivity.
• Supply chain control over high-quality excipients ensures consistency and reduces manufacturing risks.
• Partnerships with excipient suppliers can optimize formulation performance and reduce costs.

Summary of formulation trends

Formulation Type	Key Excipients	Innovation Focus
Oral tablets	Fillers, disintegrants	Taste-masking, miniaturization
Oral suspensions	Stabilizers, flavor agents	Improved bioavailability, patient adherence
Injectable	Solvents, stabilizers	Shelf-life extension, compatibility
Pediatric gels/films	Taste-masked excipients	Ease of administration

Closing thoughts

Excipients are critical to fluconazole's formulation success, with opportunities in novel excipient development and formulation strategies. The focus remains on improving stability, bioavailability, and patient compliance at competitive costs.

Key Takeaways

• Excipient selection influences stability, bioavailability, and patient acceptance for fluconazole.
• Innovation in taste-masking, disintegration, and bioavailability can create differentiation.
• Regulatory requirements vary globally, impacting excipient choice and formulation development.
• Cost-effective sourcing and supply chain control support margin expansion.
• Pediatric and specialized formulations present significant commercial growth potential.

FAQs

1. How do excipients affect fluconazole's bioavailability?
Excipients like solubilizers and disintegrants can enhance dissolution and absorption, particularly in oral formulations.

2. What excipients are commonly used in fluconazole injectables?
Water, ethanol, stabilizers, and pH adjusters like citric acid are standard.

3. Are there any safety concerns with excipients in fluconazole?
Regulatory agencies set limits on excipient types and quantities, especially for hypersensitive populations.

4. Can novel excipients extend patent protection?
Yes. Incorporating proprietary excipients or formulations can delay generic entry.

5. What trends are driving excipient innovation in antifungal drugs?
Patient compliance, stability, and bioavailability improvements are primary drivers, especially for pediatric and immunocompromised patient populations.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Excipients in DRUG Products.
[2] European Medicines Agency. (2021). Guideline on Excipients in the Labeling and Package Leaflet of Medicinal Products. [3] Pharmaceutical Technology. (2020). Formulation trends in antifungal drug delivery.