List of Excipients in Branded Drug EXTENDED PHENYTOIN SODIUM

Generic Drugs Containing EXTENDED PHENYTOIN SODIUM

Company	Ingredient	NDC	Excipient
NCS HealthCare of KY LLC dba Vangard Labs	phenytoin sodium	0615-8556	CELLULOSE, MICROCRYSTALLINE
NCS HealthCare of KY LLC dba Vangard Labs	phenytoin sodium	0615-8556	FERROSOFERRIC OXIDE
NCS HealthCare of KY LLC dba Vangard Labs	phenytoin sodium	0615-8556	GELATIN

What are the Most Frequently-Used Excipients in EXTENDED PHENYTOIN SODIUM?

# Of NDCs	Excipient
7	CELLULOSE, MICROCRYSTALLINE
4	D&C RED NO. 28
4	D&C RED NO. 33

Excipient Strategy and Commercial Opportunities for Extended Phenytoin Sodium

Last updated: February 26, 2026

What are the key excipient considerations for extended phenytoin sodium formulations?

Extended phenytoin sodium (EPS) formulations aim to optimize drug stability, bioavailability, and patient compliance. The choice of excipients impacts drug release, absorption, and shelf life.

Common excipients in EPS formulations:

• Polymers: Eudragit (methacrylate-based), hydroxypropyl methylcellulose (HPMC), ethylcellulose—used to control release profile.
• Fillers: Microcrystalline cellulose, lactose—provide bulk and stability.
• Binders and adhesives: Polyvinylpyrrolidone (PVP), hydroxypropyl cellulose—ensure tablet cohesion.
• Lubricants: Magnesium stearate, stearic acid—ease manufacturing.
• Disintegrants: Croscarmellose sodium, sodium starch glycolate—facilitate tablet breakup.

Challenges:

• Achieving predictable sustained release to avoid peak-trough fluctuations.
• Minimizing interaction with excipients that could affect stability or bioavailability.
• Ensuring biocompatibility and compliance with regulatory standards.

How does excipient selection influence commercial viability?

Excipients affect manufacturing costs, scalability, patient acceptability, and regulatory pathways.

Cost implications:

• High-purity, specialty polymers like Eudragit increase formulation costs.
• Readily available excipients like microcrystalline cellulose reduce expenses.

Patent and regulatory factors:

• Use of proprietary polymers can extend patent life.
• Regulatory acceptance varies; excipients must meet pharmacopeial standards.

Market differentiation:

• Enhanced controlled-release profiles with optimized excipients can command premium pricing.
• Formulations with fewer excipients or natural excipients appeal to specific market segments.

What are the regulatory considerations for excipient use in EPS?

Regulatory agencies such as FDA and EMA require:

• Documentation of excipient safety and compatibility.
• Stability data demonstrating excipient impact on drug shelf life.
• Clear labeling of excipients, especially for allergens or sensitivities.

Compliance pathways:

• Use of Generally Recognized as Safe (GRAS) excipients simplifies approval.
• Novel excipients need extensive safety and compatibility data.

What are potential commercial opportunities?

Market size and growth:

• The global antiepileptic drug market was valued at USD 3.17 billion in 2020 (Grand View Research, 2021).
• Extended-release formulations of phenytoin constitute about 35% of the market share for AEDs, expected to grow at 5% CAGR over the next five years.

Differentiation strategies:

• Develop formulations with improved bioavailability and fewer side effects.
• Leverage patent protections on unique excipient combinations.
• File for both brand-name and generic markets based on formulation innovations.

Partnership and licensing:

• Collaborate with excipient suppliers for proprietary Polymer or delivery technology.
• License existing controlled-release platforms to accelerate market entry.

Geographic expansion:

• Seek regulatory approval for markets with high epilepsy prevalence, including U.S., Europe, and emerging markets such as India and Brazil.

Summarized key considerations:

Aspect	Details
Excipient types	Polymers, fillers, binders, lubricants, disintegrants
Cost impact	Use of generic vs. proprietary excipients influences profitability
Regulatory hurdles	Safety data, stability studies, excipient labeling
Market opportunities	Premium formulations, patent extension, geographic expansion

Key Takeaways

• Excipient selection for extended phenytoin sodium affects drug release, stability, and manufacturing costs.
• Proprietary polymers like Eudragit can enhance patent life but may increase costs.
• Regulatory compliance depends on excipient safety, compatibility, and stability data.
• Growth in the antiepileptic market supports opportunities for innovative formulations.
• Collaborations with excipient suppliers and geographic expansion augment commercial prospects.

FAQs

1. Which excipients are most suitable for sustained-release phenytoin formulations?
   Polymers like Eudragit and HPMC are common, offering controlled release. Fillers like microcrystalline cellulose maintain tablet integrity.

2. How do excipients influence bioavailability?
   Excipients can modify drug release rate and dissolution profile, impacting absorption and plasma concentrations.

3. What are regulatory challenges associated with proprietary polymers?
   They require comprehensive safety, compatibility, and stability data, potentially complicating approval timelines.

4. Can natural excipients be used in EPS?
   Yes, but they must meet pharmacopeial standards and demonstrate consistent performance.

5. What patent strategies are applicable for excipient modifications?
   Patent new combinations, modified release mechanisms, or formulations, including novel excipient interactions.

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References

[1] Grand View Research. (2021). Antiepileptic Drugs Market Size, Share & Trends Analysis Report.