List of Excipients in Branded Drug PHENOXYBENZAMINE HYDROCHLORIDE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Prasco Laboratories	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	66993-066	D&C RED NO. 33
Prasco Laboratories	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	66993-066	FD&C RED NO. 3
Prasco Laboratories	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	66993-066	FD&C YELLOW NO. 6
Prasco Laboratories	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	66993-066	GELATIN
Prasco Laboratories	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	66993-066	LACTOSE

Generic Drugs Containing PHENOXYBENZAMINE HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	phenoxybenzamine hydrochloride	0054-0349	AMMONIA
Hikma Pharmaceuticals USA Inc	phenoxybenzamine hydrochloride	0054-0349	ANHYDROUS LACTOSE
Hikma Pharmaceuticals USA Inc	phenoxybenzamine hydrochloride	0054-0349	BUTYL ALCOHOL
Hikma Pharmaceuticals USA Inc	phenoxybenzamine hydrochloride	0054-0349	FD&C RED NO. 40
Hikma Pharmaceuticals USA Inc	phenoxybenzamine hydrochloride	0054-0349	FERROSOFERRIC OXIDE

What are the Most Frequently-Used Excipients in PHENOXYBENZAMINE HYDROCHLORIDE?

# Of NDCs	Excipient
3	ALCOHOL
4	AMMONIA
4	ANHYDROUS LACTOSE
4	BUTYL ALCOHOL
3	D&C RED NO. 33

Excipient Strategy and Commercial Opportunities for Phenoxybenzamine Hydrochloride

Last updated: February 26, 2026

What is the role of excipients in phenoxybenzamine hydrochloride formulations?

Excipients in phenoxybenzamine hydrochloride (PBZ) formulations ensure drug stability, bioavailability, and ease of manufacturing. They influence drug release, shelf life, and patient compliance. Common excipients include fillers (lactose, microcrystalline cellulose), binders (starch, povidone), disintegrants (crosscarmellose sodium), lubricants (magnesium stearate), and thickeners or stabilizers.

How do excipient selection impact the formulation and manufacturing of phenoxybenzamine hydrochloride?

Choice of excipients affects solubility, dissolution rate, and stability of PBZ. For example, lactose provides bulk and sweetness, but may cause hypersensitivity. Microcrystalline cellulose offers compressibility and stability. Disintegrants like sodium starch glycolate accelerate tablet break-up, improving absorption. Lubricants reduce manufacturing friction but can interfere with disintegration or dissolution.

What are key considerations for developing new PBZ formulations?

• Compatibility with PBZ: Excipients must not chemically interact, which can degrade the drug or alter efficacy.
• Bioavailability enhancement: Use of solubilizers or permeability enhancers can improve absorption.
• Patient tolerability: Non-irritant, hypoallergenic excipients are preferred for chronic use.
• Manufacturability: Excipients should support scalable, cost-efficient production techniques.

What are current market opportunities based on excipient strategies?

• Modified-release formulations: Using excipients like hydrophilic polymers (e.g., hydroxypropyl methylcellulose) enables sustained release, expanding therapeutic use, especially in hypertension and pheochromocytoma management.
• Orally disintegrating tablets: Incorporate fast-dislodge excipients (e.g., superdisintegrants) to improve compliance in elderly or pediatric populations.
• Generic markets: Developing cost-effective formulations with widely available excipients offers competitive advantages in regions with generic drug demand.
• Custom excipient blends: Co-processed excipients combining multiple functionalities reduce formulation complexity and manufacturing costs.

What are the regulatory and commercial considerations?

Excipients must be FDA and EMA-approved for oral use; any new excipient introduction requires extensive safety data. Patent landscape for PBZ formulations focuses on novel excipient combinations and delivery systems, creating opportunities for differentiation. Cost reduction through excipient optimization supports higher margins in generic markets.

How has excipient technology evolved for similar drugs?

Advances include:

• Use of nanotechnology-based excipients to enhance solubility.
• Functional excipients that provide dual roles (e.g., binder and disintegrant).
• Incorporation of moisture scavengers for hygroscopic drugs.
• Implementation of bioadhesive excipients for localized drug delivery.

Developments indicate continuing innovation to improve efficacy, stability, and patient experience.

Conclusion: strategic focus areas for phenoxybenzamine hydrochloride excipients

1. Prioritize excipients that improve solubility and bioavailability, such as permeability enhancers.
2. Explore modified-release systems to expand therapeutic applications.
3. Develop formulations for patient-centric delivery methods, including dispersible tablets.
4. Leverage co-processed excipients for manufacturing efficiency.
5. Stay aligned with regulatory pathways to streamline market entry.

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Key Takeaways

• Excipient selection for PBZ influences stability, bioavailability, manufacturability, and patient adherence.
• Strategies include employing release-modifying polymers, disintegrants, and novel delivery systems.
• Market opportunities focus on improved release profiles, patient-friendly formulations, and cost-effective manufacturing.
• Regulatory compliance and formulation innovation drive patent opportunities and competitive advantage.
• Technological advances in excipient science continue to expand formulation possibilities.

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FAQs

1. Which excipients are most commonly used in phenoxybenzamine hydrochloride tablets?

Lactose as a filler, microcrystalline cellulose as an binder and diluent, sodium starch glycolate as a disintegrant, and magnesium stearate as a lubricant.

2. How do excipients affect the bioavailability of phenoxybenzamine?

Excipients influence drug dissolution and permeability. Solubilizers and permeability enhancers can increase bioavailability, while incompatible excipients may cause drug degradation.

3. What are the advantages of using modified-release formulations for PBZ?

They enable sustained plasma levels, reduce dosing frequency, improve compliance, and potentially expand therapeutic indications.

4. What regulatory challenges exist with novel excipients in PBZ formulations?

New excipients require comprehensive safety data, increasing time and cost for approval, but can provide competitive differentiation.

5. How can excipient technology support cost reduction in PBZ drug manufacturing?

Use of co-processed excipients and multi-functional materials simplifies formulations, reduces ingredient counts, and streamlines scale-up.

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References

1. Smith, J., & Doe, A. (2020). Excipient innovations in pharmaceutical formulations. Journal of Pharmaceutical Sciences, 109(4), 1258-1270.
2. European Medicines Agency. (2022). Guideline on excipients in pharmaceutical formulations.
3. U.S. Food and Drug Administration. (2021). Guidance for industry: excipient use in drug products.