List of Excipients in Branded Drug PENICILLAMINE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Oceanside Pharmaceuticals	PENICILLAMINE	penicillamine	68682-020	D&C YELLOW NO. 10
Oceanside Pharmaceuticals	PENICILLAMINE	penicillamine	68682-020	GELATIN
Oceanside Pharmaceuticals	PENICILLAMINE	penicillamine	68682-020	LACTOSE MONOHYDRATE
Oceanside Pharmaceuticals	PENICILLAMINE	penicillamine	68682-020	MAGNESIUM STEARATE
Oceanside Pharmaceuticals	PENICILLAMINE	penicillamine	68682-020	TITANIUM DIOXIDE

Generic Drugs Containing PENICILLAMINE

Company	Ingredient	NDC	Excipient
Endo USA Inc	penicillamine	0254-2000	ANHYDROUS LACTOSE
Endo USA Inc	penicillamine	0254-2000	COPOVIDONE K25-31
Endo USA Inc	penicillamine	0254-2000	EDETATE DISODIUM
Endo USA Inc	penicillamine	0254-2000	HYPROMELLOSE 2910
Endo USA Inc	penicillamine	0254-2000	LACTOSE MONOHYDRATE
Endo USA Inc	penicillamine	0254-2000	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in PENICILLAMINE?

# Of NDCs	Excipient
1	ALCOHOL
6	AMMONIA
4	ANHYDROUS LACTOSE
1	BUTYL ALCOHOL
3	CELLULOSE, MICROCRYSTALLINE
1	COPOVIDONE K25-31

Penicillamine: Excipient Strategy and Commercial Opportunities

Last updated: February 28, 2026

What are the current excipient formulations for Penicillamine?

Penicillamine is an oral chelating agent primarily used for Wilson's disease, rheumatoid arthritis, and other metal poisoning cases. Its formulations generally involve the following excipients:

• Diluents: Microcrystalline cellulose, lactose monohydrate
• Binders: Povidone (PVP), hydroxypropyl methylcellulose (HPMC)
• Disintegrants: Sodium starch glycolate, cross-carmellose sodium
• Lubricants: Magnesium stearate, stearic acid
• Coating agents: Hypromellose (HPMC, for film coatings)

The typical solid dosage forms include tablets and capsules. Liquid formulations use solvents like water or glycerol, with preservatives and stabilizers.

How does excipient choice impact bioavailability and stability?

The chemical instability of penicillamine, susceptible to oxidation and hydrolysis, influences excipient selection:

• Antioxidants: Ascorbic acid or sodium bisulfite may be included to prevent oxidation.
• Moisture controls: Silica or talc may be used to reduce moisture exposure.
• pH buffers: Citrates or phosphates maintain pH stability, enhancing shelf life.
• Disintegrants: Crucial for ensuring quick release and absorption; sodium starch glycolate improves dissolution profile.

The inert nature of excipients is essential to prevent interactions that could compromise drug potency or safety.

What are the opportunities in excipient innovation for Penicillamine?

1. Enhanced bioavailability through novel delivery systems

   • Liposomal encapsulation with lipid excipients may improve absorption.
   • Polymer-based matrices (e.g., ion-exchange resins) could reduce GI irritation.

2. Reduced stability issues via stabilization excipients

   • Use of antioxidant blends tailored for oxidative sensitivity.
   • Incorporation of moisture scavengers in packaging to extend shelf life.

3. Taste masking and patient compliance

   • Development of microencapsulation or film coatings to mask metallic taste.
   • Use of flavoring excipients compatible with the active drug.

4. Alternative formulations

   • Orally disintegrating tablets for improved compliance in pediatric or elderly patients.
   • Liquid formulations with stabilized suspensions for rapid onset.

What is the competitive landscape regarding excipient patents?

Most excipients used in Penicillamine formulations are off-patent or have expired patents. However, patents may exist around specific delivery systems or stabilization techniques:

• Liposomal and nanocarrier patents exist but are not exclusive to Penicillamine.
• Coating and taste-masking formulations may carry proprietary claims.
• Custom excipient blends designed for stability can be patentable if novel.

Manufacturers exploring innovative excipient combinations can secure exclusivity via process patents, creating commercial differentiation.

What are the regulatory considerations?

Regulatory agencies require detailed excipient listings and safety data. Novel excipients or new combinations may require extensive testing for biocompatibility and stability. The FDA’s inactive ingredient database guides allowable excipients, and deviations must undergo approval.

What are the commercial incentives?

• Improving formulation stability to extend shelf life reduces distribution costs.
• Enhanced bioavailability can lead to lower dosing and improved efficacy, providing competitive advantages.
• Patient-centric formulations (taste masking, disintegrating tablets) can increase market share, particularly in pediatric markets.
• Patented delivery systems safeguard market exclusivity and provide higher margins.

Summary

Penicillamine’s formulation relies on established excipients but offers opportunities for innovation in delivery systems, stability, and patient adherence. Exploiting proprietary excipient combinations and delivery techniques can carve out market differentiation, especially with formulations targeting niche populations or improved pharmacokinetics.

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Key Takeaways

• Penicillamine formulations predominantly use standard excipients such as microcrystalline cellulose, povidone, and magnesium stearate.
• Stability and bioavailability of Penicillamine are significantly influenced by excipient choices.
• Innovation opportunities include liposomal delivery, taste masking, and disintegrating formulations.
• Patents around excipient blends or delivery methods can provide commercial exclusivity.
• Regulatory pathways demand rigorous safety and stability data, influencing formulation development.

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FAQs

1. What excipients are commonly used in Penicillamine tablets?
   Microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, and hypromellose.

2. How can excipients improve Penicillamine stability?
   By adding antioxidants, moisture controls, and pH buffers to prevent oxidation and hydrolysis.

3. Are there patents on Penicillamine formulations?
   Most active excipients are off-patent; patents may exist on specific delivery systems or coating technologies.

4. What formulation innovations could benefit Penicillamine?
   Liposomal encapsulation, taste masking via microencapsulation, and orally disintegrating tablets.

5. What regulatory challenges exist for excipient innovations?
   New or proprietary excipients require safety data and regulatory approval, which can prolong development timelines.

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References

[1] U.S. Food and Drug Administration. (2022). Inactive Ingredient Database.
[2] Choudhury, S. R., & Mohiuddin, M. (2012). Formulation and evaluation of taste masked Penicillamine. International Journal of Pharma and Bio Sciences, 3(4), 789–798.
[3] European Medicines Agency. (2019). Guideline on the stability testing of new drug substances and products.