List of Excipients in Branded Drug ZAFIRLUKAST

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	CELLULOSE, MICROCRYSTALLINE
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	CROSCARMELLOSE SODIUM
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	HYPROMELLOSE
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	LACTOSE
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	MAGNESIUM STEARATE
Major Pharmaceuticals	ZAFIRLUKAST	zafirlukast	0904-6646	POVIDONE

Generic Drugs Containing ZAFIRLUKAST

Company	Ingredient	NDC	Excipient
Rising Pharmaceuticals Inc	zafirlukast	16571-654	ANHYDROUS LACTOSE
Rising Pharmaceuticals Inc	zafirlukast	16571-654	CELLULOSE, MICROCRYSTALLINE
Rising Pharmaceuticals Inc	zafirlukast	16571-654	CROSCARMELLOSE SODIUM
Rising Pharmaceuticals Inc	zafirlukast	16571-654	FERRIC OXIDE RED
Rising Pharmaceuticals Inc	zafirlukast	16571-654	HYPROMELLOSES
Rising Pharmaceuticals Inc	zafirlukast	16571-654	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in ZAFIRLUKAST?

# Of NDCs	Excipient
1	ANHYDROUS LACTOSE
7	CELLULOSE, MICROCRYSTALLINE
4	CROSCARMELLOSE SODIUM
1	FERRIC OXIDE RED
4	HYDROXYPROPYL CELLULOSE
7	HYPROMELLOSE 2910

Excipient Strategy and Commercial Opportunities for Zafirlukast

Last updated: February 27, 2026

What is the Role of Excipients in Zafirlukast Formulations?

Excipients in Zafirlukast formulations serve multiple functions: improving drug stability, enhancing bioavailability, controlling release profiles, and ensuring manufacturability. Zafirlukast, a leukotriene receptor antagonist for asthma treatment, warrants a tailored excipient strategy to optimize efficacy and patient compliance.

What are the Typical Excipients Used in Zafirlukast Formulations?

Table 1: Common Excipients for Zafirlukast

Category	Examples	Function
Fillers/Bulking agents	Lactose monohydrate, microcrystalline cellulose	Volume increase for tablets, oral suspensions
Binders	Hydroxypropyl methylcellulose (HPMC)	Aggregating powder particles to form tablets
Disintegrants	Crospovidone, croscarmellose sodium	Promote tablet breakup in GI tract
Diluents	Dibasic calcium phosphate	Adjust dosage form size
Lubricants	Magnesium stearate	Facilitate manufacturability
Coatings	Polyvinylpyrrolidone (PVP), HPMC	Protect from moisture, control release
Preservatives	Benzalkonium chloride	Extend shelf life, prevent microbial growth

Note: Excipients for Zafirlukast are selected based on the delivery route (oral solid, liquid) and stability considerations.

How Can Excipient Optimization Improve Zafirlukast Formulations?

• Enhancing bioavailability through solubilizing agents (e.g., cyclodextrins) can mitigate poor aqueous solubility.
• Using controlled-release coatings (e.g., HPMC-based) can improve dosing convenience and compliance.
• Incorporating stabilizers (antioxidants such as ascorbic acid) extends shelf life and maintains drug potency.

What Are the Commercial Implications of Excipient Choices?

Market differentiation: Custom excipient profiles that improve onset of action, reduce dosing frequency, or enhance stability can distinguish Zafirlukast products.

Manufacturing efficiency: Selecting excipients that allow lower processing temperatures or simplified handling reduces production costs.

Regulatory advantage: Utilizing excipients with well-established safety profiles expedites regulatory approval and minimizes post-market risks.

Formulation patents: Innovative excipient combinations can lead to patentable formulations, extending market exclusivity.

What Are Emerging Trends and Opportunities?

• Nanoformulations: Incorporating nanocarriers or lipid-based carriers with specific excipients can enhance solubility and absorption.
• Biocompatible excipients: Use of plant-derived or biodegradable excipients aligns with regulatory trends toward greener pharmaceuticals.
• Personalized formulations: Adjusting excipient compositions based on patient populations (pediatric, geriatric) enhances targeted therapy.

What Are the Key Commercial Opportunities?

• Developing improved formulations with higher bioavailability and longer shelf stability
• Licensing opportunities for novel excipient combinations that optimize Zafirlukast delivery
• Contract manufacturing services focusing on excipient customization for Zafirlukast products
• Expanding indications beyond asthma, such as allergic rhinitis, with tailored formulations
• Patents for innovative controlled-release excipient matrices

Conclusion

Excipient selection for Zafirlukast directly impacts therapeutic efficacy, manufacturability, and market competitiveness. Strategies include optimizing for bioavailability, stability, and patient compliance. Opportunities exist in formulation innovation, personalized medicine, and licensing, driven by regulatory trends and advances in excipient technology.

Key Takeaways

• Excipient choices influence Zafirlukast's bioavailability, stability, and release profile.
• Tailored excipient strategies can differentiate products and extend market exclusivity.
• Emerging trends include nanotechnology and biocompatible excipients.
• Manufacturing cost reductions and patenting enable commercial advantages.
• Regulatory approval relies heavily on excipient safety profiles and compatibility.

FAQs

1. Can excipient selection affect Zafirlukast’s stability?
Yes, excipients like antioxidants and moisture barriers prevent degradation and extend shelf life.

2. Are there any regulatory restrictions on excipients used with Zafirlukast?
Excipients must be Generally Recognized As Safe (GRAS) and used within approved limits; regulatory agencies review excipient safety during drug approval.

3. How does excipient choice impact oral bioavailability?
Excipients can improve solubility or facilitate absorption, influencing drug efficacy.

4. What patents exist related to excipient formulations of Zafirlukast?
Patent landscapes include formulations with controlled-release matrices and novel excipient combinations—specific patents are subject to ongoing patent prosecution.

5. How can excipients be used to create pediatric-friendly Zafirlukast formulations?
Use of sweeteners, flavoring agents, and excipients with GRAS status suited for children enhances compliance.

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[1] Food and Drug Administration. (2021). Guidance for Industry: Nonclinical Testing of Orally Inhaled Products.