List of Excipients in Branded Drug METRONIDAZOLE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
B Braun Medical Inc	METRONIDAZOLE	metronidazole	0264-5535	ANHYDROUS CITRIC ACID
B Braun Medical Inc	METRONIDAZOLE	metronidazole	0264-5535	SODIUM CHLORIDE
B Braun Medical Inc	METRONIDAZOLE	metronidazole	0264-5535	SODIUM PHOSPHATE, DIBASIC
B Braun Medical Inc	METRONIDAZOLE	metronidazole	0264-5535	WATER
Baxter Healthcare Corporation	METRONIDAZOLE	metronidazole	0338-1055	ANHYDROUS CITRIC ACID
Baxter Healthcare Corporation	METRONIDAZOLE	metronidazole	0338-1055	SODIUM CHLORIDE
Baxter Healthcare Corporation	METRONIDAZOLE	metronidazole	0338-1055	SODIUM PHOSPHATE, DIBASIC

Generic Drugs Containing METRONIDAZOLE

Company	Ingredient	NDC	Excipient
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	CARBOMER HOMOPOLYMER TYPE C
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	EDETATE DISODIUM
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	METHYLPARABEN
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	PROPYLENE GLYCOL
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	PROPYLPARABEN
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	SODIUM HYDROXIDE
Amneal Pharmaceuticals of New York LLC	metronidazole	0115-1474	WATER

What are the Most Frequently-Used Excipients in METRONIDAZOLE?

# Of NDCs	Excipient
3	ALCOHOL
1	AMMONIA
8	ANHYDROUS CITRIC ACID
16	ANHYDROUS LACTOSE
11	BENZYL ALCOHOL
5	BETADEX
1	BUTYL ALCOHOL

Excipient Strategy and Commercial Opportunities for Metronidazole

Last updated: February 25, 2026

What are optimal excipient strategies for Metronidazole formulations?

Metronidazole is a nitroimidazole antibiotic primarily used against anaerobic bacteria and protozoa. Its physicochemical properties—poor aqueous solubility, variable bioavailability, and chemical stability—dictate excipient selection.

Excipient considerations for formulation stability and bioavailability

• Solubilizers: Polyethylene glycol (PEG) and surfactants such as polysorbates enhance solubility, crucial for oral solutions and suspensions. Cyclodextrins form inclusion complexes improving dissolution.

• pH Adjusters: Acidic or mildly basic buffers optimize stability and absorption. Citrates buffer formulations to pH 4.5–5.0, stabilizing the drug during manufacturing and storage.

• Fillers and Binders: Microcrystalline cellulose and lactose serve as binders and diluents in tablets, providing weight uniformity without compromising bioavailability.

• Disintegrants: Sodium starch glycolate and croscarmellose sodium facilitate tablet disintegration, enhancing dissolution.

• Preservatives and antioxidants: Parabens and ascorbic acid maintain chemical stability, especially in aqueous formulations.

Formulation-specific excipient strategies

Formulation Type	Excipient Strategy
Oral Tablets	Use of fillers, binders, disintegrants, film-coating agents, and flavoring excipients tailored to patient compliance
Topical Creams	Emollients, stabilizers, and preservatives to ensure stability and skin compatibility
Intravaginal Gels, suppositories	Gelling agents such as carbomers, surfactants for mucosal adhesion, and preservatives

Regulatory and quality considerations

• Excipients must be selected based on regulatory approval status in target markets (FDA, EMA).

• Compatibility testing ensures excipient-drug interactions do not reduce efficacy or cause degradation.

What are the commercial opportunities associated with excipient innovation?

Market growth and unmet needs

• The global metronidazole market is projected to reach USD 560 million by 2027, driven by rising antimicrobial resistance and demand for cost-effective oral and topical formulations (Fortune Business Insights, 2022).

• Oral formulations account for approximately 65% of sales, with suspensions for pediatric use and extended-release tablet products expanding opportunities.

Novel excipient applications

• Nanoparticle carriers: Incorporating metronidazole into liposomal or nanoemulsion delivery systems can increase bioavailability and target site concentration, addressing resistant strains.

• Taste-masking excipients: Improving patient compliance, especially in pediatric formulations, through complexation with ion-exchange resins or coating technologies.

• Stability-enhancing excipients: Development of moisture scavengers and antioxidants tailored for long shelf-life products.

Supply chain and partnership opportunities

• Establishing partnerships with excipient manufacturers to develop proprietary formulations with improved stability or bioavailability.

• Innovating in supply chain logistics to ensure consistent quality and regulatory compliance across markets.

Patent landscape and innovation barriers

• Current patents cover specific excipients and delivery systems; locating gaps allows for patent filing and market entry.

• Avoiding patent infringement by selecting excipients with broad approval or developing novel combinations.

Summary of key data points

Parameter	Data/Insight
Global metronidazole market size (2022)	USD 330 million
Compound stability window	2 years at room temperature when stabilized with antioxidants
Excipient approval rate	98% of oral excipients are generally recognized as safe (GRAS) in the US
Market growth CAGR (2022–2027)	7.2%

Key Takeaways

• Excipient choice for metronidazole formulations addresses solubility, stability, and patient compliance.

• Innovation in nanoparticle and taste-masking excipients offers significant commercial upside.

• Regulatory landscape favors excipient approval and compatibility testing to facilitate market entry.

• Collaboration with excipient suppliers can lead to differentiated products and patent opportunities.

FAQs

1. How does excipient selection affect metronidazole bioavailability?
Excipients like cyclodextrins and surfactants improve solubility, directly influencing absorption. Proper pH buffers sustain stability and optimize gastrointestinal uptake.

2. Which excipients are most common in metronidazole tablets?
Microcrystalline cellulose (filler), croscarmellose sodium (disintegrant), povidone (binder), and magnesium stearate (lubricant) are routinely used.

3. What innovations can improve patient compliance?
Taste-masking agents, extended-release formulations, and formulations suitable for pediatric or geriatric populations address compliance issues.

4. Are there regulatory challenges in excipient development for metronidazole?
Yes, excipients must be approved in target markets. Novel excipients require extensive safety and compatibility testing.

5. What strategic moves can companies make in this market?
Investing in novel excipient formulations, establishing supply chain partnerships, and filing patents for innovative delivery systems can offer competitive advantage.

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References

[1] Fortune Business Insights. (2022). Metronidazole Market Size, Share & Industry Analysis. https://www.fortunebusinessinsights.com/industry-reports/metronidazole-market

[2] U.S. Food and Drug Administration. (2021). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm