List of Excipients in Branded Drug PHENDIMETRAZINE TARTRATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Eon Labs Inc	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	0185-5254	FD&C BLUE NO. 1
Eon Labs Inc	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	0185-5254	FD&C RED NO. 40
Eon Labs Inc	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	0185-5254	GELATIN
Eon Labs Inc	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	0185-5254	POVIDONE

Generic Drugs Containing PHENDIMETRAZINE TARTRATE

Company	Ingredient	NDC	Excipient
Eon Labs Inc	phendimetrazine tartrate	0185-4057	FD&C YELLOW NO. 5
Eon Labs Inc	phendimetrazine tartrate	0185-4057	LACTOSE MONOHYDRATE
Eon Labs Inc	phendimetrazine tartrate	0185-4057	POVIDONE
Eon Labs Inc	phendimetrazine tartrate	0185-4057	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in PHENDIMETRAZINE TARTRATE?

# Of NDCs	Excipient
3	CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
27	CELLULOSE, MICROCRYSTALLINE
7	CROSCARMELLOSE SODIUM
9	D&C YELLOW NO. 10

Excipient Strategy and Commercial Opportunities for Phendimetrazine Tartrate

Last updated: February 27, 2026

What is the role of excipients in the formulation of phendimetrazine tartrate?

Excipients serve as inactive ingredients that stabilize, facilitate manufacturing, improve bioavailability, and enhance patient compliance of phendimetrazine tartrate tablets. They influence drug shelf life, release profile, and manufacturing efficiency. Typical excipients include fillers (lactose, microcrystalline cellulose), binders (starch), disintegrants (croscarmellose sodium), lubricants (magnesium stearate), and flavoring agents.

How do excipient choices impact formulation stability and bioavailability?

Selecting appropriate excipients enhances stability by preventing degradation (e.g., oxidation, hydrolysis) and moisture absorption. For phendimetrazine tartrate, moisture-sensitive excipients safeguard integrity, especially given its sensitivity to humidity. Disintegrants affect dissolution rate, impacting bioavailability. Use of salt form (tartrate) already improves solubility, but excipients can further optimize dissolution, absorption, and onset of action.

What are current excipient trends relevant to phendimetrazine tartrate?

Emerging trends include the shift toward:

• Low-Gluten or Gluten-Free Excipients: To accommodate patients with sensitivities. Lactose-free options like microcrystalline cellulose are preferred.

• Non-Irritating Disintegrants: Croscarmellose sodium replaces older, harsher agents, improving patient comfort.

• HPMC (Hydroxypropyl Methylcellulose) in Controlled-Release Formulations: Enables sustained release, potentially reducing dosing frequency.

• Biodegradable Lubricants: Replacing traditional magnesium stearate to reduce potential for absorption interference and allergenicity.

How does excipient strategy influence manufacturing and supply chain?

Choice of excipients impacts manufacturing costs, scalability, and regulatory compliance. For generic manufacturers, compatibility with existing machinery simplifies scale-up. Excipients with broad supply chains reduce risk of shortages. Incorporating excipients with GRAS (Generally Recognized As Safe) status expedites regulatory approval.

What are the market opportunities associated with excipient innovation?

Potential areas include:

• Development of Modified-Release Formulations: Using novel excipients in controlled-release versions of phendimetrazine tartrate can extend patent life and create premium products.

• Personalized Medicine: Formulations with excipients tailored for specific populations (e.g., pediatric, elderly) offer differentiation.

• Combination Products: Using excipients to enable fixed-dose combinations with other weight-loss agents or appetite suppressants.

• Sustainability: Incorporating excipients derived from renewable sources responds to increasing environmental concerns.

What regulatory considerations shape excipient strategies?

Regulatory authorities, notably the FDA and EMA, require documentation of excipient safety, stability, and compatibility. Novel excipients demand extensive safety testing and approval pathways. Incorporating excipients with established safety profiles accelerates approval. Documentation must include stability data, compatibility studies, and excipient supplier quality assurance.

Summary of key excipient considerations

Aspect	Details
Stability	Use moisture-barrier excipients, antioxidants as needed
Bioavailability	Optimize disintegrants and dissolution modifiers
Manufacturing	Select excipients compatible with existing processes, suppliers
Regulatory	Prioritize excipients with approved status, clear safety data
Market	Explore controlled-release, fixed-dose combinations, sustainability

Key Opportunities

• Develop controlled-release formulations using HPMC or other polymers.
• Explore gluten-free and allergen-reduced excipients.
• Create combination products with complementary drugs.
• Use excipients with eco-friendly sourcing for sustainability.
• Leverage excipient technology to extend patent protection via new formulations.

FAQs

1. What excipients are most commonly used in phendimetrazine tartrate tablets?
Lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and flavoring agents.

2. How can excipient selection improve drug stability?
By choosing moisture-resistant excipients, antioxidants, and packaging materials that reduce environmental exposure.

3. What are the main regulatory hurdles for introducing new excipients?
Demonstrating safety and compatibility through stability, toxicity, and bioavailability studies.

4. Can excipient innovation extend the patent life of phendimetrazine formulations?
Yes. Reformulating with novel or modified excipients, especially for controlled-release or combination products, can provide new patent opportunities.

5. How does excipient strategy influence patient compliance?
Improved taste, reduced irritation, and once-daily dosing via controlled-release formulations enhance adherence.

References

[1] U.S. Food and Drug Administration. (2019). Inactive Ingredients Database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCIGenerator/Default.cfm
[2] EMA. (2021). Guideline on Excipients in the Labels of Medicinal Products for Human Use. European Medicines Agency.
[3] Rathore, A. S., & Schaub, N. J. (2018). Formulation strategies for controlled-release oral drug delivery systems. Journal of Controlled Release, 292, 174–188.