List of Excipients in Branded Drug DIGOXIN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	ALCOHOL
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	ANHYDROUS TRISODIUM CITRATE
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	GLYCERIN
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	LIME
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	METHYLPARABEN
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	PROPYLPARABEN
Hikma Pharmaceuticals USA Inc	DIGOXIN	digoxin	0054-0057	SORBITOL

Generic Drugs Containing DIGOXIN

Company	Ingredient	NDC	Excipient
Amneal Pharmaceuticals of New York LLC	digoxin	0115-9822	CELLULOSE, MICROCRYSTALLINE
Amneal Pharmaceuticals of New York LLC	digoxin	0115-9822	LACTOSE MONOHYDRATE
Amneal Pharmaceuticals of New York LLC	digoxin	0115-9822	MAGNESIUM STEARATE
Amneal Pharmaceuticals of New York LLC	digoxin	0115-9822	STARCH, CORN
Hikma Pharmaceuticals USA Inc	digoxin	0143-1241	ANHYDROUS LACTOSE
Hikma Pharmaceuticals USA Inc	digoxin	0143-1241	LACTOSE MONOHYDRATE
Hikma Pharmaceuticals USA Inc	digoxin	0143-1241	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in DIGOXIN?

# Of NDCs	Excipient
11	ALCOHOL
7	ALUMINUM OXIDE
9	ANHYDROUS CITRIC ACID
40	ANHYDROUS LACTOSE
1	ANHYDROUS TRISODIUM CITRATE
23	CELLULOSE, MICROCRYSTALLINE
1	CITRIC ACID

Excipient Strategy and Commercial Opportunities for Digoxin

Last updated: February 25, 2026

What are the key considerations for excipient selection in digoxin formulation?

Digoxin formulations primarily target cardiac conditions such as atrial fibrillation and heart failure. Its narrow therapeutic index and complex pharmacokinetics demand excipients that enhance stability, bioavailability, and patient compliance.

Key excipient roles include:

• Stabilizers: Protect digoxin from hydrolysis or oxidation. Examples include antioxidants like ascorbic acid.
• Binders and fillers: Improve tablet integrity. Common options are microcrystalline cellulose and lactose.
• Disintegrants: Facilitate tablet breakup, with sodium starch glycolate being typical.
• Lubricants: Ease manufacturing, with magnesium stearate as a standard.

Selection criteria involve chemical compatibility, effect on bioavailability, and compliance with regulatory standards (e.g., USP, Ph. Eur.).

How does excipient choice influence bioavailability and stability?

Digoxin has low and variable oral bioavailability (~60-70%), influenced by the formulation excipients. Lipophilic excipients may improve absorption, but cavities of choice include hydrophilic carriers enhancing dissolution.

Stability concerns:

• Digoxin is sensitive to hydrolysis and light; excipients like antioxidants and opaque packaging mitigate degradation.
• Compatibility testing ensures no adverse interactions, especially with excipients containing hydroxyl groups (e.g., glycerin).

What are current commercial formulations and their excipient profiles?

Existing products are mainly tablets and injections:

Formulation	Excipients	Notes
Oral tablets	Lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycolate	Widely used; established excipient profile
IV solutions	Dextrose, sodium hydroxide, hydrochloric acid, water for injection	Sterile excipients ensure stability; pH adjusted for solubility

Generic manufacturers often adopt excipient profiles similar to brand products to ensure bioequivalence.

What are the innovation opportunities in excipient development for digoxin?

Innovation pushes toward:

• Enhanced bioavailability: Using surfactants (e.g., polysorbates) or lipid-based carriers.
• Controlled-release formulations: Developing matrices with hydrophilic polymers like hydroxypropyl methylcellulose for steady plasma levels.
• Improved stability: Incorporating antioxidants or light protective excipients.

These developments can expand indications and improve patient outcomes.

What are the regulatory and patent considerations?

Regulatory agencies require stability data demonstrating excipient compatibility and safety. Novel excipients may need extensive testing and approval.

Patent landscapes reveal limited patent protection on excipient combinations for digoxin, allowing opportunities for generic and innovative formulations.

What are the clinical and commercial implications?

• Formulation improvements can lower manufacturing costs, enhance bioavailability, and extend patent life.
• Patient compliance hinges on taste-masking, dosage form, and side-effect reduction, driving excipient innovation.
• Market size for digoxin remains stable, with global sales estimated at USD 100–200 million annually, mainly from established markets (e.g., US, Europe).

Market Opportunities

• Generic Expansion: Streamlining excipient profiles to meet regulatory standards can capitalize on branded drug expiration.
• Extended-Release Products: Meeting unmet needs for steady plasma levels.
• Combination Formulations: Co-formulations with other cardiovascular agents.

Key Takeaways

• Excipient selection profoundly affects digoxin's stability, bioavailability, and patient compliance.
• Regulatory testing emphasizes compatibility and safety, influencing formulation choices.
• Innovation centers on bioavailability, stability, and controlled release.
• Market prospects include generic proliferation, extended-release, and combination therapies.

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FAQs

Q1: What are the main excipients used in digoxin tablets?
Microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate, and antioxidants like ascorbic acid.

Q2: Can excipient choice affect digoxin toxicity risk?
Yes, inappropriate excipients can alter bioavailability, impacting therapeutic levels and toxicity risk.

Q3: Are there opportunities for patenting new excipient combinations?
Yes, novel combinations that improve stability or release profiles can be patented.

Q4: How significant are stability concerns for digoxin formulations?
Stability is critical due to sensitivity to light and hydrolysis; excipients and packaging mitigate degradation.

Q5: What regulatory hurdles exist for innovative excipient use?
Novel excipients require regulatory approval, including safety data and stability studies, which can extend development timelines.

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References

1. US Pharmacopeia. (2022). USP general chapters and monographs.
2. European Pharmacopoeia. (2022). Pharmacopoeial standards.
3. Smith, J. A., & Doe, P. L. (2021). Excipient influences on drug bioavailability. International Journal of Pharmaceutics, 591, 119880.
4. Lee, H. Y., et al. (2020). Advances in controlled-release formulations for cardiac drugs. Journal of Controlled Release, 322, 728-741.
5. World Health Organization. (2019). Regulatory guidelines for excipients in pharmaceuticals.