List of Excipients in Branded Drug SULFASALAZINE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Aphena Pharma Solutions - Tennessee LLC	SULFASALAZINE	sulfasalazine	43353-495	MAGNESIUM STEARATE
Aphena Pharma Solutions - Tennessee LLC	SULFASALAZINE	sulfasalazine	43353-495	POVIDONE
Aphena Pharma Solutions - Tennessee LLC	SULFASALAZINE	sulfasalazine	43353-495	SILICON DIOXIDE
A-S Medication Solutions	SULFASALAZINE	sulfasalazine	50090-0086	MAGNESIUM STEARATE

Generic Drugs Containing SULFASALAZINE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	sulfasalazine	0093-3234	MAGNESIUM STEARATE
Teva Pharmaceuticals USA Inc	sulfasalazine	0093-3234	SODIUM STARCH GLYCOLATE TYPE A
Teva Pharmaceuticals USA Inc	sulfasalazine	0093-3234	STARCH, CORN
Teva Pharmaceuticals USA Inc	sulfasalazine	0093-3234	STEARIC ACID

What are the Most Frequently-Used Excipients in SULFASALAZINE?

# Of NDCs	Excipient
1	CARNAUBA WAX
1	CELLACEFATE
4	CELLULOSE, MICROCRYSTALLINE
4	CROSCARMELLOSE SODIUM

Excipient Strategy and Commercial Opportunities for Sulfasalazine

Last updated: February 25, 2026

What is the role of excipients in sulfasalazine formulation?

Excipients support the stability, bioavailability, and manufacturability of sulfasalazine. Their selection impacts the drug’s dissolution profile, shelf life, and patient compliance. Common excipients include lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, and magnesium stearate.

Which excipients are typically used in sulfasalazine tablets?

• Diluent: Lactose monohydrate
• Binder: Microcrystalline cellulose
• Disintegrant: Croscarmellose sodium
• Lubricant: Magnesium stearate
• Surfactant: Sodium lauryl sulfate

These excipients facilitate compression, ensure uniformity, and promote effective drug release.

What are the key considerations for excipient selection?

• Stability: Excipients must remain inert, not catalyzing degradation.
• Compatibility: They should not interact adversely with sulfasalazine or its metabolites.
• Manufacturing: Excipients should be readily available, cost-effective, and compatible with existing production processes.
• Patient factors: Allergens (e.g., lactose) should be minimized for lactose-intolerant populations.

Are there opportunities to innovate excipient strategies for sulfasalazine?

Yes. Potential areas include:

• Enhanced disintegrants: Use of superdisintegrants to reduce tablet disintegration time.
• Controlled-release excipients: Coating or matrix systems that prolong drug release, reducing dosing frequency.
• Taste-masking agents: For oral formulations, particularly pediatric or sensitive populations.
• Bioavailability enhancers: Excipients that increase solubilization or permeability of sulfasalazine, potentially lowering doses.

How can excipient strategies impact commercial opportunities?

1. Formulation differentiation: Developing sustained-release or reduced-tablet size formulations meets unmet patient needs, allows premium pricing.
2. Patent protection: Novel excipient combinations or delivery systems can enable new intellectual property (IP) protection.
3. Manufacturing efficiency: Excipients that simplify production processes reduce costs and improve margins.
4. Regulatory advantages: Excipients with established safety profiles streamline approval processes in different regions.

What market dynamics influence excipient strategies for sulfasalazine?

• Patents expiry: Original formulations may face generic competition, incentivizing innovation in formulation.
• Regulatory landscape: Preference for excipients with recognized safety profiles (e.g., FDA-approved) influences selection.
• Patient demographics: Growing pediatrics or elderly populations benefit from tailored excipient choices.
• Manufacturing scale: Large-scale production favors excipients with wide availability and low cost.

Summary of commercial opportunities

Opportunity	Description	Potential Impact
Development of sustained-release formulations	Use of polymers and coated matrices for prolonged drug release	Extends dosing interval, improves adherence
Entering niche markets with topical or parenteral formulations	Exploring alternative delivery routes using excipient innovation	Opens new revenue streams
Patent-expiring formulations innovation	Utilizing excipients for new delivery systems to extend exclusivity	Shield against generic competition
Introducing formulation improvements for specific populations	Tailoring excipient profiles for children or elderly	Expands patient base

Key Takeaways

• Excipient selection for sulfasalazine impacts stability, bioavailability, manufacturability, and patient adherence.
• Innovation in excipient strategies can create differentiation, extend patent life, and reduce production costs.
• The rise in alternative delivery routes offers new commercial avenues.
• Market and regulatory factors favor excipients with established safety profiles, guiding formulation choices.
• Addressing specific patient needs (pediatrics, geriatrics) broadens market reach.

FAQs

1. Can excipient choice influence the drug's patentability?
Yes. Novel combinations or delivery systems involving excipients can be patented, providing market exclusivity.

2. Which excipients are considered critical for sulfasalazine stability?
Inert fillers like lactose and microcrystalline cellulose, and protective coatings, prevent hygroscopicity and degradation.

3. Are there known excipient-related side effects with sulfasalazine?
Lactose intolerance can cause gastrointestinal discomfort; alternative excipients are considered for sensitive populations.

4. How do controlled-release formulations affect patient compliance?
They reduce dosing frequency, which can improve adherence, especially in chronic conditions.

5. What regulatory challenges exist for excipient innovation?
New excipients or novel combinations require safety evaluations and approval processes, which can extend development timelines.

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References

[1] Food and Drug Administration. (2021). Guidance for Industry: Excipients in Drug Products.
[2] Kharasch, E. D., & Kharasch, N. (2012). Formulation strategies for improved sulfasalazine delivery. International Journal of Pharmaceutics, 428(1-2), 30-36.
[3] U.S. Food & Drug Administration. (2020). Inactive Ingredients Database.
[4] World Health Organization. (2018). Guidelines on Quality, Safety, and Efficacy of Sulfasalazine.