List of Excipients in Branded Drug OMEPRAZOLE DELAYED-RELEASE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Ranbaxy Laboratories Inc	OMEPRAZOLE DELAYED-RELEASE	omeprazole	63304-445	BUTYL ALCOHOL
Ranbaxy Laboratories Inc	OMEPRAZOLE DELAYED-RELEASE	omeprazole	63304-445	CELLULOSE, MICROCRYSTALLINE
Ranbaxy Laboratories Inc	OMEPRAZOLE DELAYED-RELEASE	omeprazole	63304-445	D&C RED NO. 28
Ranbaxy Laboratories Inc	OMEPRAZOLE DELAYED-RELEASE	omeprazole	63304-445	D&C YELLOW NO. 10
Ranbaxy Laboratories Inc	OMEPRAZOLE DELAYED-RELEASE	omeprazole	63304-445	FD&C BLUE NO. 1

Generic Drugs Containing OMEPRAZOLE DELAYED-RELEASE

Company	Ingredient	NDC	Excipient
DOH CENTRAL PHARMACY	omeprazole	53808-0745	ALCOHOL
DOH CENTRAL PHARMACY	omeprazole	53808-0745	AMMONIA
DOH CENTRAL PHARMACY	omeprazole	53808-0745	BUTYL ALCOHOL
DOH CENTRAL PHARMACY	omeprazole	53808-0745	FERRIC OXIDE RED
DOH CENTRAL PHARMACY	omeprazole	53808-0745	FERROSOFERRIC OXIDE

What are the Most Frequently-Used Excipients in OMEPRAZOLE DELAYED-RELEASE?

# Of NDCs	Excipient
1	ALCOHOL
1	AMMONIA
1	BUTYL ALCOHOL
1	FERRIC OXIDE RED
1	FERROSOFERRIC OXIDE

Excipient Strategy and Commercial Opportunities for Omeprazole Delayed-Release Formulation

Last updated: March 1, 2026

What is the role of excipients in delayed-release omeprazole?

Excipients in omeprazole delayed-release formulations (DR) serve key functions:

• Protect omeprazole from stomach acid degradation.
• Control the timing of drug release in the intestine.
• Ensure stability and bioavailability of the active pharmaceutical ingredient (API).

Common excipients include enteric coatings, disintegrants, binders, and stabilizers.

What are the leading excipient types used in omeprazole DR products?

Enteric Coatings

• Polyvinyl acetate phthalate (PVAP) – used in branded formulations.
• Hydroxypropyl methylcellulose phthalate (HPMCP) – common for dissolving in intestinal pH.
• Cellulose acetate phthalate (CAP) – employed in some generic products.

Release Modifiers

• Ethyl cellulose – used for controlled-release variants.
• Polyethylene glycol (PEG) – stabilizes API and enhances solubility.

Stabilizers and Antioxidants

• Ascorbic acid – included in some formulations to increase stability in vivo.
• Tocopherols – used to minimize oxidation.

How do excipient choices impact commercial manufacturing?

• Cost and supply chain: Excipients like HPMCP are widely available, reducing supply risks.
• Formulation complexity: The choice of coating affects process parameters, scale-up, and batch variability.
• Regulatory considerations: Excipients with established safety profiles accelerate approval pathways.

What are recent innovations in excipient strategies for omeprazole DR?

• Use of more stable polymer coatings that resist high humidity and temperature during manufacturing.
• Integration of multi-layer coatings for combined acid protection and controlled release.
• Development of polymer blends that optimize dissolution profiles, minimizing variability.

What commercial opportunities exist with excipient enhancements?

Value-added formulations

• Extended-release variants: Designed for once-daily dosing, appealing to patients requiring long-term therapy.
• Combination products: Co-formulated with antacids or other gastroprotectants, created using excipients compatible with multifunctional delivery.

Cost reduction and supply chain efficiency

• Use of excipients sourced from global suppliers with stable pricing reduces manufacturing costs.
• Adoption of excipients with proven long-term stability minimizes batch failures and delays.

Differentiation in generic markets

• Employing innovative excipient blends allows for patent estate strategies and market differentiation.
• Developing formulations with improved shelf stability or fewer excipient-related side effects enhances value.

Regulatory advantages

• Excipients already approved in multiple markets streamline global approval processes.
• Compatibility with existing manufacturing infrastructure reduces capital investments.

What are competitive considerations in excipient selection?

• Approval status and safety profile.
• Manufacturing and processing compatibility.
• Cost and availability.
• Patent status and potential for exclusivity.

Summary of key drivers influencing excipient strategy:

Driver	Impact
Stability	Ensures product efficacy over shelf life
Bioavailability	Optimizes API delivery to target site
Cost	Affects gross margins and market pricing
Manufacturing	Determines scalability and quality consistency
Regulatory	Influences time-to-market and approval costs

Closing remarks

Efficient excipient selection is critical for both manufacturing performance and commercial success of delayed-release omeprazole products. Strategic innovation and supply chain optimization can open new market opportunities, particularly in high-margin branded segments and generic formulations targeting emerging markets.

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Key Takeaways

• Excipients like HPMCP, CAP, and ethyl cellulose are standard in omeprazole delayed-release formulations.
• Advances include multi-layer coatings and polymer blends to improve stability and dissolution.
• Opportunities exist in extending patent life, enhancing product stability, and developing combination therapies.
• Cost and supply chain considerations influence excipient choices; regulatory status streamlines global commercialization.
• Innovations in excipient technology can differentiate products and reduce manufacturing risk.

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FAQs

1. How does the choice of enteric coating affect omeprazole's performance?
It determines the pH range at which the API is released, protecting it from stomach acid and ensuring release in the intestine.

2. Can excipient variability impact bioavailability?
Yes, inconsistent excipient quality or composition can lead to batch-to-batch variability in drug release and absorption.

3. Are there patent strategies associated with excipient formulations?
Yes, developing unique excipient blends or coatings can create patentable aspects that extend market exclusivity.

4. What regulatory challenges are linked to excipient selection?
Using excipients with limited safety data or novel formulations can delay approval or require additional testing.

5. How can innovation in excipients create new commercial opportunities?
By improving stability, efficacy, or patient adherence, excipient innovations can support premium pricing and market differentiation.

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References

[1] U.S. Food and Drug Administration (FDA). (2010). Guidance for Industry: Stability Testing of Drug Substances and Products.
[2] European Medicines Agency (EMA). (2019). Guideline on pharmaceutical quality systems.
[3] Nield, J., & Simpson, B. (2018). Pharmaceutical excipients: Regulatory perspectives and recent advancements. International Journal of Pharmaceutics, 543(1), 1–12.
[4] Patel, S., & Joshi, G. (2020). Advances in enteric coatings for oral drug delivery systems. DARU Journal of Pharmaceutical Sciences, 28, 49.