List of Excipients in Branded Drug PROPYLTHIOURACIL

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Endo USA Inc	PROPYLTHIOURACIL	propylthiouracil	67253-651	CELLULOSE, MICROCRYSTALLINE
Endo USA Inc	PROPYLTHIOURACIL	propylthiouracil	67253-651	DOCUSATE SODIUM
Endo USA Inc	PROPYLTHIOURACIL	propylthiouracil	67253-651	MAGNESIUM STEARATE
Endo USA Inc	PROPYLTHIOURACIL	propylthiouracil	67253-651	SODIUM BENZOATE
Endo USA Inc	PROPYLTHIOURACIL	propylthiouracil	67253-651	SODIUM GLYCOLATE

Generic Drugs Containing PROPYLTHIOURACIL

Company	Ingredient	NDC	Excipient
Actavis Pharma Inc	propylthiouracil	0228-2348	LACTOSE MONOHYDRATE
Actavis Pharma Inc	propylthiouracil	0228-2348	MAGNESIUM STEARATE
Actavis Pharma Inc	propylthiouracil	0228-2348	POVIDONE
Actavis Pharma Inc	propylthiouracil	0228-2348	SILICON DIOXIDE
Actavis Pharma Inc	propylthiouracil	0228-2348	STARCH, CORN

What are the Most Frequently-Used Excipients in PROPYLTHIOURACIL?

# Of NDCs	Excipient
4	ANHYDROUS LACTOSE
1	CALCIUM STEARATE
5	CELLULOSE, MICROCRYSTALLINE
1	COLLOIDAL SILICON DIOXIDE
4	LACTOSE MONOHYDRATE

Excipient Strategy and Commercial Opportunities for Propylthiouracil

Last updated: February 27, 2026

What are the current excipient strategies for Propylthiouracil (PTU)?

Propylthiouracil (PTU) is an antithyroid medication used to manage hyperthyroidism. Its formulation typically involves excipients that ensure stability, bioavailability, and patient compliance.

Standard formulations and excipient roles:

• Active Ingredient: Propylthiouracil (PTU).
• Common excipients:
  • Lactose monohydrate: filler and diluent.
  • Microcrystalline cellulose: binder and disintegrant.
  • Magnesium stearate: lubricant.
  • Croscarmellose sodium: disintegrant.
  • Cornstarch: binder and disintegrant.

Formulation considerations:

• Oral tablet forms dominate.
• Liquid suspensions are less common but employed for pediatric use.
• Excipients must be compatible with PTU, which can degrade under certain conditions.

How do excipient choices influence formulation and market differentiation?

Excipients impact drug stability, taste, absorption, and patient adherence:

• Stability: Excipients like magnesium stearate prevent tablet caking and enhance shelf life.
• Taste masking: Flavors and sweeteners can be used, especially in suspensions.
• Bioavailability: Disintegrants and binders facilitate dissolution and absorption.
• Patient compliance: Convenient forms (e.g., dispersible tablets with pleasant excipients) improve adherence.

Differentiators include:

• Enhanced stability profiles through novel excipient combinations.
• Low excipient allergenicity appealing to sensitive populations.
• Use of smaller excipient quantities to reduce side effects and allergic reactions.

What are the commercial opportunities in excipient innovation for PTU?

Opportunities include:

1. Formulation improvements:

   • Development of dispersible or sustained-release tablets.
   • Incorporation of taste-masking agents for pediatric use.

2. Excipient patenting:

   • Creating proprietary excipient blends unique to PTU formulations.
   • Patent filings around stabilizers or disintegrants tailored to PTU.

3. Market expansion:

   • Launch of new dosage forms that expand into pediatric or elderly segments.
   • Compatibility with novel drug delivery platforms (e.g., films, patches).

4. Regulatory incentives:

   • 505(b)(2) pathways for reformulated PTU with novel excipients.
   • Orphan drug designation if targeting specific populations.

Competitive landscape:

• Major pharmaceutical companies may invest in excipient innovations to distinguish products.
• Contract manufacturing organizations (CMOs) offer specialized formulation development.
• Generic manufacturers seek excipient strategies to extend patent life or improve product stability.

Challenges:

• Ensuring excipient compatibility with PTU's chemical stability.
• Regulatory hurdles for novel excipients.
• Cost considerations for reformulation.

What regulatory considerations influence excipient choices?

• Excipient approval status varies by region, requiring compliance with agencies like the FDA and EMA.
• Safety data: excipients must meet purity standards and have established safety profiles.
• Labeling requirements specify excipient content.
• For pediatric formulations, excipients must be non-toxic and suitable for children.

Summary table: Excipient options and their implications

Excipient	Function	Impact on PTU Formulation	Regulatory Note
Lactose monohydrate	filler	Cost-effective, common	Generally recognized as safe (GRAS)
Microcrystalline cellulose	binder	Enhances disintegration	Well established in formulations
Magnesium stearate	lubricant	Protects stability	Widely approved
Croscarmellose sodium	disintegrant	Faster dissolution	Typically approved
Sweeteners / Flavors	taste-masking	Improves compliance	Food additive regulations

Key market trends and future outlook:

• Increasing demand for pediatric-friendly PTU formulations.
• Rising investment in excipient innovation for long-acting or targeted delivery.
• Focus on minimizing excipient-related adverse reactions.

Key Takeaways

• Current PTU formulations rely on standard excipients like lactose, microcrystalline cellulose, and magnesium stearate.
• Excipient choices affect stability, bioavailability, and patient adherence.
• Innovation opportunities include developing novel excipient blends, taste-masked formulations, or sustained-release products.
• Patent protection for proprietary excipient combinations can provide competitive advantage.
• Regulatory considerations demand compliance with safety and approval standards, especially for pediatric formulations.

FAQs

1. What excipients are essential in Propylthiouracil formulations?
Lactose monohydrate, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, and flavoring agents are common.

2. Can excipient innovation extend PTU's market life?
Yes. Proprietary or improved excipients can enable new dosage forms, enhance stability, and meet regulatory requirements for reformulation.

3. Are there opportunities for sustained-release PTU formulations?
Potentially. Developing excipient matrices that enable controlled release could improve dosing frequency and adherence.

4. What challenges exist in reformulating PTU with new excipients?
Chemical stability, regulatory approval, cost, and ensuring excipient compatibility with PTU are primary challenges.

5. How does excipient choice influence PTU's pediatric market?
Choice of non-toxic, pleasant-tasting excipients enhances compliance and safety, crucial for pediatric formulations.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Nonclinical Safety Testing of Drug and Biological Products.
[2] EMA. (2017). Guideline on Excipients in the Labeling and Packaging of Medicinal Products.
[3] World Health Organization. (2018). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Marketed formulations database.