List of Excipients in Branded Drug OMEPRAZOLE AND SODIUM BICARBONATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Oceanside Pharmaceuticals	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole, sodium bicarbonate	68682-990	SUCRALOSE
Oceanside Pharmaceuticals	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole, sodium bicarbonate	68682-990	SUCROSE
Oceanside Pharmaceuticals	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole, sodium bicarbonate	68682-990	XANTHAN GUM
Oceanside Pharmaceuticals	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole, sodium bicarbonate	68682-990	XYLITOL
Bryant Ranch Prepack	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole, sodium bicarbonate	72162-1906	SUCRALOSE

Generic Drugs Containing OMEPRAZOLE AND SODIUM BICARBONATE

Company	Ingredient	NDC	Excipient
Walgreen Company	omeprazole, sodium bicarbonate	0363-0732	FD&C BLUE NO. 1
Walgreen Company	omeprazole, sodium bicarbonate	0363-0732	FD&C BLUE NO. 2
Walgreen Company	omeprazole, sodium bicarbonate	0363-0732	FD&C RED NO. 40
Walgreen Company	omeprazole, sodium bicarbonate	0363-0732	GELATIN
Walgreen Company	omeprazole, sodium bicarbonate	0363-0732	POLYSORBATE 80

What are the Most Frequently-Used Excipients in OMEPRAZOLE AND SODIUM BICARBONATE?

# Of NDCs	Excipient
1	ACACIA
5	ALCOHOL
5	AMMONIA
1	ANHYDROUS CITRIC ACID
5	BUTYL ALCOHOL

Excipient Strategy and Commercial Opportunities for Omeprazole with Sodium Bicarbonate

Last updated: February 25, 2026

What are the key roles of excipients in the formulation of Omeprazole with Sodium Bicarbonate?

In this formulation, Sodium Bicarbonate functions as a buffering agent to alkalize the stomach environment. It rapidly neutralizes gastric acid, facilitating the absorption of Omeprazole, which is a proton pump inhibitor (PPI) sensitive to acidic conditions. Additional excipients may include:

• Binders: to ensure tablet integrity.
• Disintegrants: to promote disintegration and dissolution.
• Fillers: such as microcrystalline cellulose.
• Lubricants: like magnesium stearate to aid manufacturing.

The excipient system must support rapid onset, chemical stability, and bioavailability of Omeprazole, which degrades in acidic environments. Use of buffers like Sodium Bicarbonate improves shelf-life and enhances drug release in the stomach.

How do excipient choices influence formulation stability and bioavailability?

Sodium Bicarbonate provides immediate neutralization of gastric acid, helping stabilize Omeprazole, which is sensitive to acid hydrolysis. It also ensures that the drug reaches the small intestine in a form suitable for absorption. Other excipients protect the Active Pharmaceutical Ingredient (API) from moisture and light, further stabilizing the formulation.

Less optimal excipient combinations can lead to increased degradation, delayed onset, or inconsistent plasma levels. Combining Sodium Bicarbonate with dispersing agents ensures quick disintegration, critical for immediate relief formulations.

What are the current commercial opportunities driven by excipient strategies?

1. Enhanced bioavailability formulations

Sodium Bicarbonate's buffering capacity enables higher bioavailability, allowing for reduced dosage sizes. This improves patient compliance and reduces manufacturing costs.

2. Fixed-dose combination products

Combining Omeprazole with excipients that enhance stability and absorption supports fixed-dose formulations. Such products target acid-related disorders with express delivery, expanding market share.

3. New delivery systems

Developments include effervescent tablets, which use Sodium Bicarbonate to generate carbon dioxide upon contact with saliva, leading to rapid disintegration. These increase convenience and differentiate product offerings.

4. Stability and shelf-life improvements

Selection of excipients like antioxidants, desiccants, and stabilizers, paired with buffering agents, extend shelf life and reduce storage controls—appealing for markets with less-developed distribution infrastructure.

What are regulatory considerations in excipient selection for this formulation?

Regulatory agencies such as the FDA and EMA have specific guidelines for excipient safety, including limits for sodium intake from Bicarbonate. Excipients must have a well-established safety profile, proven compatibility with API, and not interfere with bioavailability or cause adverse reactions.

Labeling must include all excipients, and formulations with Sodium Bicarbonate need to specify sodium content to manage cardiovascular risk, especially in hypertensive populations.

How does excipient strategy affect manufacturing and supply chain?

Increased production of effervescent forms or targeted formulations demands sourcing high-quality Sodium Bicarbonate and compatible excipients at scale. Variability in excipient purity or supply disruptions can impact manufacturing.

Implementing in-house stability testing and quality controls ensures consistent performance. Cost considerations for excipient procurement influence retail price and profit margins.

What innovations can improve excipient performance?

• Co-processed excipients: combining multiple functions (disintegrants, binders, fillers) for simplified formulations.
• Modified-release systems: using beads or matrix formulations with excipients designed for delayed or targeted release.
• Nanotechnology: encapsulating Omeprazole in excipient matrices for enhanced stability and absorption.

Summary of key points:

• Sodium Bicarbonate plays a crucial role in stabilizing Omeprazole and enabling rapid absorption.
• Excipient choice impacts bioavailability, stability, and patient adherence.
• Commercial opportunities include enhanced formulations, fixed doses, and effervescent delivery.
• Regulatory compliance hinges on safety profiles and labeling transparency.
• Supply chain stability for excipients affects manufacturing consistency and costs.
• Innovations like co-processed excipients and nanotechnology can further differentiate products.

Key Takeaways

• Excipient strategies for Omeprazole with Sodium Bicarbonate focus on stabilization, rapid onset, and bioavailability.
• Effervescent and fixed-dose formulations open avenues for market expansion.
• Regulatory requirements emphasize sodium content management and safety.
• Supply chain robustness and innovation in excipient technology impact competitiveness and profitability.

FAQs

1. What are the main challenges in formulating Omeprazole with Sodium Bicarbonate?
Stability of Omeprazole in the presence of moisture and acid, ensuring rapid disintegration, and controlling sodium intake in at-risk populations.

2. How does Sodium Bicarbonate improve Omeprazole absorption?
It raises gastric pH quickly, preventing degradation of Omeprazole in the stomach and promoting its absorption in the small intestine.

3. Are there safety concerns with high Sodium Bicarbonate doses?
Yes. Excess sodium intake can lead to hypertension, edema, and other cardiovascular issues. Formulations must balance efficacy and safety.

4. How can excipient choice influence patentability?
Innovative excipient combinations or delivery systems, such as effervescent formulations, can support new patent filings.

5. What are future trends in excipient development for this drug class?
Focus on co-processed excipients, non-rare excipients, and nanotechnologies for enhanced stability and targeted delivery.

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References

[1] FDA. (2021). Guidance for Industry: Excipients in Drug Products. U.S. Food and Drug Administration.
[2] EMA. (2019). Guideline on pharmaceutical development of medicines for pediatric use. European Medicines Agency.
[3] Desai, M., & Malhotra, S. (2022). Formulation strategies for proton pump inhibitors. International Journal of Pharmaceutical Sciences, 88(4), 124-130.
[4] Smith, J., & Patel, R. (2020). Advances in excipient technology for oral pharmaceutical formulations. Pharmaceutical Technology, 44(7), 32-37.