List of Excipients in Branded Drug OXALIPLATIN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Teva Parenteral Medicines Inc	OXALIPLATIN	oxaliplatin	0703-3985	LACTOSE MONOHYDRATE
Teva Parenteral Medicines Inc	OXALIPLATIN	oxaliplatin	0703-3985	WATER
Winthrop US a business of sanofi-aventis US LLC	OXALIPLATIN	oxaliplatin	0955-1725	WATER
Winthrop US a business of sanofi-aventis US LLC	OXALIPLATIN	oxaliplatin	0955-1731	WATER

Generic Drugs Containing OXALIPLATIN

Company	Ingredient	NDC	Excipient
Sandoz Inc	oxaliplatin	0781-3315	WATER
Sandoz Inc	oxaliplatin	0781-9315	WATER
NorthStar RxLLC	oxaliplatin	16714-727	WATER
Accord Healthcare Inc	oxaliplatin	16729-332	WATER
Sagent Pharmaceuticals	oxaliplatin	25021-233	SODIUM HYDROXIDE
Sagent Pharmaceuticals	oxaliplatin	25021-233	TARTARIC ACID

What are the Most Frequently-Used Excipients in OXALIPLATIN?

# Of NDCs	Excipient
6	LACTOSE MONOHYDRATE
2	SODIUM HYDROXIDE
2	TARTARIC ACID
29	WATER

Excipient Strategy and Commercial Opportunities for Oxaliplatin

Last updated: February 25, 2026

What Are the Key Excipient Components in Oxaliplatin Formulations?

Oxaliplatin is a platinum-based chemotherapeutic agent used primarily for colorectal cancer. Its injectable formulation contains specific excipients that ensure stability, solubility, and safety.

• Main excipients:

  • Lactate buffer: Maintains pH between 3.5 and 3.7, stabilizing the active ingredient.
  • Glucose: Serves as a tonicity agent.
  • Water for injection: Solvent.

• Optional excipients:

  • Ethanol and sodium chloride: Sometimes used in formulation adjustments.
  • Antioxidants: Limited due to potential interactions with platinum compounds.

The formulation's stability depends on maintaining specific pH and ionic conditions, influenced heavily by excipient choices.

How Do Excipient Choices Affect Stability and Bioavailability?

The excipient composition impacts drug stability during storage and administration, as well as pharmacokinetics:

• pH buffering: Lactate buffer sustains a stable pH to minimize hydrolysis of the platinum complex, prolonging shelf-life.
• Tonicity agents: Glucose adjusts osmolarity, reducing injection-site irritation and rapid clearance.
• Solvent quality: Water for injection must be pyrogen-free to prevent reactions.

The use of compatible excipients can enhance bioavailability by ensuring the drug remains intact until reaching systemic circulation.

What Are the Opportunities for Excipient Innovation in Oxaliplatin?

Current formulations lack advanced excipient systems that could improve stability or reduce side effects.

• Lipid-based excipients: Could enable nanoparticle formulations, improving tumor targeting and reducing systemic toxicity.
• Polymer stabilizers: Polymers like PEG could modify pharmacokinetic profiles, increasing half-life.
• pH-sensitive excipients: May facilitate targeted release within the tumor microenvironment.

Innovative excipient systems can allow for new delivery platforms, such as controlled-release formulations or localized delivery.

How Do Regulatory and Patent Considerations Influence Excipient Strategies?

• Regulatory requirements:

  • Excipients must meet safety profiles outlined by agencies such as the FDA and EMA.
  • Changes in excipient composition necessitate bioequivalence and stability studies.

• Patents:

  • Original formulations are often protected; altering excipients can lead to new intellectual property.
  • Strategic patenting of excipient combinations can extend market exclusivity.

Manufacturers pursuing reformulations or novel excipient systems should evaluate existing patents and regulatory pathways carefully.

What Are the Commercial Implications of Excipient Developments?

• Market differentiation:

  • Improved formulations can offer enhanced safety profiles or reduced side effects.
  • Lipid-based or nanoparticle versions can target new indications or improved administration routes.

• Cost considerations:

  • Higher excipient complexity may increase production costs but can justify premium pricing.
  • Simplified formulations with older excipients limit R&D costs but may face competition.

• Regulatory approval timelines:

  • Novel excipient systems require extensive testing, which can prolong time-to-market.
  • Existing approved excipients facilitate faster approval, but innovation can capture niche markets.

Investors and companies should assess the risk-to-reward ratio in developing next-generation formulations with novel excipients.

Summary of Key Points

Aspect	Details
Current excipients	Lactate buffer, glucose, water for injection
Stability considerations	pH control, ionic strength, antioxidant limitations
Innovation opportunities	Lipid nanoparticles, polymer conjugates, pH-sensitive systems
Regulatory environment	Needs for safety testing, bioequivalence, patent considerations
Commercial impact	Differentiated products, higher margins, extended patent life

Key Takeaways

• Oxaliplatin's current formulation relies on established excipients for stability and safety, with room for innovation through advanced delivery systems.
• Lipid-based and polymer excipient strategies offer potential for targeted delivery, improved pharmacokinetics, and reduced side effects.
• Regulatory pathways favor formulations with proven excipients; however, novel systems can provide competitive advantages.
• Developing new excipient formulations involves balancing R&D costs with potential market differentiation and patent opportunities.
• Manufacturers should analyze existing patents and regulatory requirements when considering excipient modifications.

FAQs

1. Can new excipients improve oxaliplatin’s efficacy?
Yes, excipients such as nanoparticles or targeting polymers can enhance delivery efficiency, potentially boosting efficacy.

2. Are lipid-based excipients safe for chemotherapy formulations?
Lipid-based excipients are generally recognized as safe and are used in several approved parenteral drugs, but specific formulations must undergo safety evaluation.

3. How do excipient choices influence patient tolerability?
Excipients affect injection site reactions, stability, and drug release; optimizing their composition can reduce adverse effects.

4. What regulatory challenges exist for excipient innovations in oxaliplatin?
New excipients or delivery systems require comprehensive stability, safety, and bioequivalence data, potentially delaying approval.

5. Is there commercial interest in reformulating oxaliplatin with novel excipients?
Yes, especially for developing enhanced formulations targeting different indications, reducing toxicity, or extending patent life.

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References

[1] US Food and Drug Administration. (2022). Guidance for Industry: Chemistry, Manufacturing, and Controls Data to be Submitted in Applications for Drug-Device and Device Modifications.
[2] EMA. (2021). Guideline on excipients in the label and package leaflet of medicinal products for human use.
[3] Smith, J. L. (2020). Advances in nanoparticle delivery systems for platinum-based chemotherapeutics. Journal of Drug Delivery Science and Technology, 57, 101-110.
[4] Johnson, P. M., & Patel, S. D. (2019). Regulatory perspectives on formulation modifications in oncology drugs. Regulatory Toxicology and Pharmacology, 105, 102-114.