Last updated: February 26, 2026
What is Ultravisit and its Formulation?
Ultravisit is a non-ionic, water-soluble contrast agent containing iopamidol (370 mg/mL). It is used primarily for radiographic imaging, including computed tomography (CT) scans. Ultravisit’s formulation relies on specific excipients to ensure stability, bioavailability, and compatibility.
Primary Ingredients and Excipients:
- Active ingredient: Iopamidol
- Excipients:
- Sodium chloride: maintains isotonicity
- Water for injection
- Sodium hydroxide or hydrochloric acid: pH adjustment
- Preservatives (in some formulations): to prevent microbial contamination
Current Excipient Strategy
Selection Principles
Excipients in Ultravisit are selected based on several criteria:
- Compatibility with iopamidol
- Stability over shelf life
- Minimal adverse reactions
- Ease of manufacturing and sterilization
Key Excipient Roles:
- Buffering agents: Maintain pH (~6-8) to prevent precipitation
- Salts (NaCl): Achieve isotonicity, reducing discomfort upon injection
- Preservatives: Ensure sterility without compromising stability
- Water for Injection: Solvent basis
Proprietary or Custom-Formulated Excipients
Ultravisit does not contain complex proprietary excipients. Its formulation employs standard pharmaceutical excipients aligned with USP/EP standards, highlighting regulatory familiarity and ease of manufacturing.
Opportunities in Excipient Optimization
1. Enhanced Stability
Introducing stabilizers such as trehalose or amino acids could extend shelf life and improve thermal stability, reducing storage constraints and supply chain risks.
2. Improved Tolerance
Replacing sodium chloride with more biocompatible salts (e.g., mannitol) may reduce injection-related adverse effects, enhancing patient comfort and safety.
3. Osmotic Balance
Formulation adjustments that optimize osmotic effects could minimize irritation and improve imaging clarity, offering a competitive edge.
4. Preservation and Sterility
Developing preservative-free formulations using single-use pre-filled syringes addresses aseptic concerns and meets increasing demand for preservative-free injectables.
Commercial Opportunities
1. Excipient Innovation and Patent Extensions
Innovating excipient combinations or delivery systems can create new patent portfolios for Ultravisit. Patents focused on stability, tolerability, or sterilization can extend product lifecycle and market exclusivity.
2. Partnership with Excipient Suppliers
Collaborating with excipient manufacturers to develop tailored excipient blends provides differentiation. Securing supply agreements reduces manufacturing risks and can lead to cost efficiencies.
3. Market Expansion through Formulation Differentiation
Enhanced formulations with optimized excipients can address unmet needs, such as:
- Reduced injection pain
- Higher stability for tropical or resource-limited settings
- Compatibility with advanced imaging modalities
4. Regulatory Pathways
Regulatory submissions for modifications citing new excipient use can be streamlined if based on well-understood excipients. These modifications facilitate approval for new markets or reduced dosing protocols.
5. Biosimilar and Localization Strategies
Technological advancements in excipient compatibility enable production of biosimilar contrast agents tailored for emerging markets with specific excipient regulation standards.
Regulatory Landscape and Considerations
1. Quality Standards
Maximize compliance with USP, EP, and JP monographs for excipients and finished products. Use of GRAS (Generally Recognized As Safe) excipients expedites regulatory approval.
2. Labeling and Safety Data
Any excipient modifications require comprehensive safety and stability testing. Patents on excipient combinations depend on demonstrating equivalence or improved functionality.
3. International Harmonization
Align formulation changes with ICH guidelines (Q5C for degradation products, Q3C for residual solvents) to facilitate approval in global markets.
Conclusion
Ultravisit's excipient strategy hinges on establishing stability, biocompatibility, and regulatory compliance through standard excipients. Opportunities lie in innovating formulations with stabilizers, preservative-free systems, and tailored excipient blends. These enhancements can extend product lifecycle, address patient safety concerns, and open new markets.
Key Takeaways
- Ultravisit’s formulation relies on standard excipients such as sodium chloride, water, and pH adjusters.
- Opportunities for commercialization include developing stability-enhanced formulations and preservative-free options.
- Patent extension through excipient innovation can create competitive advantages.
- Regulatory pathways favor well-characterized excipients, simplifying approval.
- Partnerships with excipient suppliers can optimize supply chain and formulation performance.
FAQs
1. Can excipient modifications extend Ultravisit’s shelf life?
Yes. Incorporating stabilizers or buffer agents can enhance stability, reducing degradation risks.
2. What excipients could reduce injection discomfort?
Using biocompatible salts or osmotic agents may lower discomfort associated with injection.
3. Are proprietary excipients a viable strategy for Ultravisit?
Potentially. Proprietary excipients can differentiate formulations but must offer proven benefits and comply with regulations.
4. How do excipient changes impact regulatory approval?
Regulatory bodies require safety and stability data. Well-characterized excipients streamline approval for formulation modifications.
5. Is there a trend toward preservative-free contrast agents?
Yes. The industry favors preservative-free formulations to reduce allergic reactions and improve safety profiles.
References
[1] U.S. Pharmacopeia. (2022). USP monograph for Iopamidol.
[2] European Pharmacopoeia. (2022). Monograph for Iopamidol.
[3] ICH Guideline Q3C. (2021). Residual solvents.
[4] ICH Guideline Q5C. (2014). Quality of biotechnological products: stability testing of biotechnological/biological products.
