List of Excipients in Branded Drug WAL SOM

Generic Drugs Containing WAL SOM

Company	Ingredient	NDC	Excipient
Walgreen Company	doxylamine succinate	0363-0441	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Walgreen Company	doxylamine succinate	0363-0441	CELLULOSE, MICROCRYSTALLINE
Walgreen Company	doxylamine succinate	0363-0441	DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Walgreen Company	doxylamine succinate	0363-0441	FD&C BLUE NO. 1
Walgreen Company	doxylamine succinate	0363-0441	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in WAL SOM?

# Of NDCs	Excipient
1	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
1	CELLULOSE, MICROCRYSTALLINE
1	DIBASIC CALCIUM PHOSPHATE DIHYDRATE
1	FD&C BLUE NO. 1
1	MAGNESIUM STEARATE

Excipient Strategy and Commercial Opportunities for WAL SOM

Last updated: February 26, 2026

What is the excipient profile of WAL SOM?

WAL SOM, a novel pharmaceutical compound, requires a tailored excipient strategy to enhance stability, bioavailability, and manufacturability. Its formulation likely involves excipients that address solubility, stability, and patient acceptability.

Typical excipient categories for WAL SOM:

• Solubilizers: Enhancers for poorly soluble drugs, such as cyclodextrins or surfactants.
• Stabilizers: Antioxidants, pH buffers, or preservatives to prevent degradation.
• Fillers and binders: Microcrystalline cellulose or lactose, used in solid dosage forms.
• Disintegrants: To facilitate tablet breakup, such as croscarmellose sodium.
• Lubricants: Magnesium stearate for manufacturing.

How does the excipient strategy impact commercial development?

An optimized excipient profile can:

• Reduce manufacturing costs through streamlining formulation processes.
• Improve drug stability, extending shelf life and reducing returns.
• Enable multiple dosage forms, expanding market reach.
• Comply with regulatory standards, accelerating approval timelines.

What are the key considerations for excipient selection?

• Compatibility: The excipient must not interact adversely with WAL SOM.
• Regulatory status: GRAS (Generally Recognized As Safe) list inclusion accelerates approval.
• Supply chain stability: Reliable sources for consistent quality.
• Cost-effectiveness: Keeping formulations economically viable.

What commercial opportunities exist through excipient innovation?

• Patent extensions: Developing unique excipient combinations can create patent barriers.
• New dosage forms: Transdermal patches, dissolving tablets, or nasal sprays open markets.
• Enhanced bioavailability formulations: Delivering WAL SOM more effectively can command premium pricing.
• Global market expansion: Regulatory pathways favoring excipient transparency or established safety profiles enable faster approval in multiple jurisdictions.

How do regulatory agencies influence excipient strategy?

• Agencies such as the FDA and EMA specify excipient safety and permissible concentrations.
• Use of novel or non-standard excipients may require additional testing or bridging studies.
• Regulatory guidance influences development timelines and costs.

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Key Opportunities for WAL SOM

Opportunity Area	Details
Patent protection via excipient combos	Formulation patents can shield market exclusivity.
Expanded dosage forms	Transdermal or nasal formulations address unmet medical needs.
Bioavailability enhancement	Nanoparticle or lipid-based excipients improve absorption.
Regulatory incentives	Approved excipients shortcut approval processes.
Market diversification	Global markets prefer formulations with well-known excipients.

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Key Takeaways

• Excipient selection is critical for WAL SOM’s stability, manufacturability, and market acceptance.
• Developing proprietary excipient combinations can foster patent positions.
• Formulation innovations can expand market share through new dosage forms and improved bioavailability.
• Regulatory considerations heavily influence excipient and formulation choices.
• Supply chain integrity and cost control in excipient sourcing drive commercial success.

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FAQs

Q1: What factors are most important when selecting excipients for WAL SOM?
Compatibility with the active pharmaceutical ingredient, regulatory approval status, supply reliability, and cost-effectiveness are primary factors.

Q2: Can excipient innovation extend WAL SOM’s patent life?
Yes, unique combinations or new formulations using excipients can be patented, providing market exclusivity advantages.

Q3: What are the potential risks associated with excipient choices?
Interactions that reduce stability, regulatory delays due to non-standard excipients, or supply chain disruptions.

Q4: How does excipient selection influence global market access?
Use of well-documented, globally accepted excipients simplifies regulatory approval and reduces time to market.

Q5: What are emerging trends in excipient technology relevant to WAL SOM?
Nanotechnology for enhanced bioavailability, multifunctional excipients reducing formulation complexity, and environmentally sustainable excipient sourcing.

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References

1. Fontana, A., et al. (2021). Formulation and manufacturing considerations for pharmaceuticals. International Journal of Pharmaceutics, 597, 120236.
2. U.S. Food and Drug Administration. (2022). Guidance for industry: Excipients in pharmaceuticals. https://www.fda.gov
3. European Medicines Agency. (2022). Guideline on excipients in the dossier for application. https://www.ema.europa.eu