List of Excipients in Branded Drug FUROSEMIDE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Hikma Pharmaceuticals USA Inc	FUROSEMIDE	furosemide	0143-9155	HYDROCHLORIC ACID
Hikma Pharmaceuticals USA Inc	FUROSEMIDE	furosemide	0143-9155	SODIUM CHLORIDE
Hikma Pharmaceuticals USA Inc	FUROSEMIDE	furosemide	0143-9155	SODIUM HYDROXIDE
Hikma Pharmaceuticals USA Inc	FUROSEMIDE	furosemide	0143-9155	WATER

Generic Drugs Containing FUROSEMIDE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	furosemide	0054-4297	CELLULOSE, MICROCRYSTALLINE
Hikma Pharmaceuticals USA Inc	furosemide	0054-4297	LACTOSE MONOHYDRATE
Hikma Pharmaceuticals USA Inc	furosemide	0054-4297	SILICON DIOXIDE
Hikma Pharmaceuticals USA Inc	furosemide	0054-4297	SODIUM LAURYL SULFATE

What are the Most Frequently-Used Excipients in FUROSEMIDE?

# Of NDCs	Excipient
1	ALCOHOL
51	ANHYDROUS LACTOSE
60	CELLULOSE, MICROCRYSTALLINE
2	COLLOIDAL SILICON DIOXIDE

Excipient Strategy and Commercial Opportunities for FUROSEMIDE

Last updated: February 26, 2026

What are key excipient considerations for FUROSEMIDE formulations?

FUROSEMIDE, a loop diuretic used primarily for edema and hypertension, requires specific excipient strategies to ensure stability, bioavailability, and patient compliance. Its poorly water-soluble nature and pH sensitivity influence excipient selection.

Essential excipient functions in FUROSEMIDE formulations:

• Solubilizers: Enhancing aqueous solubility. Microcrystalline cellulose and sodium starch glycolate can improve dissolution.
• Disintegrants: Promote tablet disintegration; choice impacts onset of action.
• Binders: Ensure tablet integrity; povidone is common.
• Lubricants: Facilitate manufacturing; magnesium stearate is standard.
• Sweeteners and flavoring agents: Improve palatability, especially for pediatric formulations.

Formulation challenges:

• Hydrolytic stability: Excipients that interact with FUROSEMIDE and cause degradation must be avoided.
• pH compatibility: Many excipients influence GI pH and drug dissolution rates.
• Bioavailability: Excipient impact on absorption is critical, especially for oral tablets and solutions.

Excipient innovations:

• Use of cyclodextrins to improve solubility.
• Incorporation of nanoparticle carriers.
• Development of orally disintegrating tablets with fast-acting disintegrants.

What are current regulatory and industry standards?

• The US FDA and EMA specify excipient safety profiles, emphasizing inertness and purity.
• Labeling requires disclosure of all excipients, especially for pediatric products.
• Excipients such as benzyl alcohol and certain preservatives are restricted due to toxicity concerns in neonates.

What commercial strategies leverage excipient innovation?

Product differentiation:

• Fast-dissolving films and orally disintegrating tablets enhance patient compliance.
• Liquid formulations with solubilizing excipients serve pediatric and geriatric patients.

Pipeline development:

• New excipient combinations aimed at improving bioavailability.
• Stabilizing excipients to extend shelf life under varied storage conditions.

Partnership opportunities:

• Collaborate with excipient manufacturers to develop proprietary solutions.
• License novel excipients that improve stability or absorption.

Regulatory pathways:

• Employing abbreviated pathways for reformulated products with optimized excipients.
• Demonstrating excipient safety through biocompatibility studies.

What are the key market opportunities?

Market Segment	Opportunity Description	Estimated Market Size (USD)	Growth Drivers
Pediatric formulations	Developing liquid or dispersible forms with compatible excipients	5 billion (2021)	Rising chronically ill pediatric populations
Geriatric formulations	Fast-dissolving tablets to improve compliance in elderly patients	8 billion (2021)	Aging global population; increasing multimorbidity
Combination products	Fixed-dose combinations with other antihypertensives or diuretics	15 billion (2021)	Patient preference; simplified dosing regimens
Biosimilar extensions	Utilizing novel excipients to improve stability and bioavailability in generics	Not directly applicable	Cost reduction; patent expiration of branded formulations

What are regulatory outlooks and hurdles?

• Regulatory agencies scrutinize excipient safety, especially in vulnerable populations.
• Pathways for reformulations with new excipients require biocompatibility testing.
• Approval timelines vary; early engagement with regulators is essential.

What are future research directions?

• Investigate biodegradable, plant-based excipients for sustainability and safety.
• Develop targeted delivery systems to reduce dosages and side effects.
• Explore nanotechnology-based excipients for improved penetration and absorption.

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Key Takeaways

• Excipient selection for FUROSEMIDE hinges on solubility, stability, and bioavailability.
• Innovations like cyclodextrins and nanoparticle carriers provide formulation advantages.
• Market opportunities focus on pediatric, geriatric, and combination therapies.
• Regulatory compliance influences excipient choices and reformulation strategies.
• Industry collaborations and research into novel excipients can enable product differentiation.

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FAQs

Q1: What excipient types are avoided in FUROSEMIDE formulations?
Certain preservatives and excipients like benzyl alcohol are restricted, especially in neonatal formulations, to prevent toxicity.

Q2: How do excipients affect FUROSEMIDE bioavailability?
Excipients influence drug solubilization, dissolution, and stability, directly impacting absorption rates.

Q3: Are there sustainable excipient options for FUROSEMIDE?
Yes, biodegradable and plant-based excipients are under investigation for improved safety and environmental profile.

Q4: What formulation alternatives exist besides tablets?
Liquid solutions, dispersible tablets, and orally disintegrating strips alongside innovative excipients cater to various patient needs.

Q5: How can excipient innovation extend FUROSEMIDE patent life?
Reformulating with novel excipients that improve stability or bioavailability can qualify for new patents and extended market exclusivity.

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References

1. U.S. Food and Drug Administration. (2022). Guidance for Industry: Excipients in Drug Products.
2. European Medicines Agency. (2022). Guideline on the Requirements for the Use of Excipients in Medicinal Products.
3. Kwon, Y. J., et al. (2021). Cyclodextrins for drug delivery: Advances and challenges. International Journal of Pharmaceutics, 601, 120568.
4. Smith, J. E., & Nguyen, T. H. (2020). Recent developments in nanoparticle-based delivery systems for poorly soluble drugs. Current Pharmaceutical Design, 26(8), 927-943.