List of Excipients in Branded Drug SUCRALFATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Pharmaceutical Associates Inc	SUCRALFATE	sucralfate	0121-0747	FD&C RED NO. 40
Pharmaceutical Associates Inc	SUCRALFATE	sucralfate	0121-0747	GLYCERIN
Pharmaceutical Associates Inc	SUCRALFATE	sucralfate	0121-0747	METHYLPARABEN
Pharmaceutical Associates Inc	SUCRALFATE	sucralfate	0121-0747	SORBITOL

Generic Drugs Containing SUCRALFATE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA, Inc.	sucralfate	0093-2210	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA, Inc.	sucralfate	0093-2210	MAGNESIUM STEARATE
Teva Pharmaceuticals USA, Inc.	sucralfate	0093-2210	STARCH, CORN
PAI Holdings LLC dba PAI Pharma	sucralfate	0121-0974	BENZOIC ACID

What are the Most Frequently-Used Excipients in SUCRALFATE?

# Of NDCs	Excipient
1	ALCOHOL
6	BENZOIC ACID
3	BENZYL ALCOHOL
55	CELLULOSE, MICROCRYSTALLINE

Excipient Strategy and Commercial Opportunities for Sucralfate

Last updated: February 25, 2026

How do excipients impact the formulation of Sucralfate?

Sucralfate's formulation relies heavily on specific excipients to ensure stability, bioavailability, and ease of administration. Standard excipients include citric acid, sodium hydroxide, and purified water, which facilitate the formation of the viscous, gel-like substance that coats ulcers. Excipients affect the drug’s physical properties, shelf life, and tolerability.

Key excipient considerations:

• Disintegrants and fillers: To improve handling and dosage form integrity. Common fillers include microcrystalline cellulose.
• pH buffers: Citric acid and sodium hydroxide maintain optimal pH for stability and efficacy.
• Binders and stabilizers: To enhance physical stability during manufacturing and storage.

What are current manufacturing trends for excipients in Sucralfate?

Manufacturers increasingly utilize high-purity excipients compliant with pharmacopeia standards. There’s a move toward:

• Reduced excipient load: To mitigate adverse effects or drug interactions.
• Novel excipients: Such as modified cellulose derivatives for improved bioadherence.
• Customization: Tailoring excipients for specific delivery forms like oral suspension or tablets.

How do excipient choices influence commercial opportunities?

Excipient strategies directly impact manufacturing costs, regulatory approvals, and market differentiation. Firms that optimize excipients for:

• Enhanced bioavailability: Can justify premium pricing.
• Better patient compliance: Via improved taste or reduced side effects.
• Extended shelf life: Minimizes waste and supply chain risks.

This opens avenues for formulation innovation, including sustained-release capabilities or novel dosage forms that meet specific unmet needs.

What market segments are targeted with specialized excipient formulations?

Commercial opportunities are concentrated in:

• Generic markets: Companies seeking cost-effective excipient substitutions without losing efficacy.
• Branded formulations: Differentiated by improved patient experience or stability.
• Hospital and institutional sales: Requiring high-volume production with strict quality standards.

Distributors offering customized excipient blends for Sucralfate face less competition, particularly in emerging markets.

What regulatory considerations influence excipient strategies?

Regulatory bodies like the FDA, EMA, and PMDA emphasize excipient purity, labeling, and safety data. Using GRAS (Generally Recognized as Safe) excipients streamlines approval processes. Patent considerations affect innovation:

• Patent expiration: Drives cost-focused excipient strategies.
• Novel excipients: May provide patentable formulation advantages but face more rigorous approval.

Which commercial opportunities stem from formulation innovation?

Opportunities include:

• Enhanced formulations: For example, orally disintegrating tablets with superdisintegrants.
• Combination products: Sucralfate combined with other agents for enhanced therapy.
• New delivery formats: Such as topical gels or sustained-release injectables.

Companies investing in excipient science can capture premium segments and expand into niche markets.

Summary of key excipient and market dynamics:

Aspect	Details	Impact
Excipient purity	Use of USP/EP compliant excipients	Reduces regulatory risk
Formulation innovation	Use of novel excipients	Differentiates products, enhances bioavailability
Cost optimization	Reduced excipient load	Lowers manufacturing costs
Delivery formats	Tablets, suspensions, gels	Expands market reach

Key Takeaways

• Excipient choices influence Sucralfate’s stability, efficacy, and patient adherence.
• Innovations in excipient technology can lead to premium formulations.
• Regulatory standards shape excipient selection and market entry.
• Cost-effective excipient strategies support generic and emerging markets.
• Customized excipient blends enable product differentiation.

Frequently Asked Questions

1. What are the main excipients in Sucralfate formulations?
   Citric acid, sodium hydroxide, purified water, and fillers like microcrystalline cellulose.

2. How can excipient innovation improve Sucralfate’s marketability?
   By enhancing stability, bioavailability, or patient tolerability, leading to differentiated products.

3. What regulatory challenges exist for new excipient use in Sucralfate?
   New excipients face approval hurdles; using GRAS excipients simplifies regulatory pathways.

4. Can excipient strategy affect patent prospects?
   Yes; novel excipients may secure new patents or extend exclusivity.

5. What trends are shaping future excipient use in gastrointestinal drugs?
   Focus on reducing excipient load, adopting advanced delivery systems, and using biocompatible materials.

---

References
[1] U.S. Food and Drug Administration. (2021). Guidance for Industry: Excipients in Drug Products.

[2] European Medicines Agency. (2022). Guideline on Excipients in the Labeling and Packaging of Medicinal Products.

[3] Kolar, R., et al. (2020). Advances in formulation of sucralfate: a comprehensive review. Journal of Drug Delivery Science and Technology, 55, 101556.