List of Excipients in Branded Drug GUAIFENESIN D

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Walgreen Company	GUAIFENESIN D	guaifenesin and pseudoephedrine hydrochloride	0363-9930	CARBOMER HOMOPOLYMER TYPE B
Walgreen Company	GUAIFENESIN D	guaifenesin and pseudoephedrine hydrochloride	0363-9930	CELLULOSE, MICROCRYSTALLINE
Walgreen Company	GUAIFENESIN D	guaifenesin and pseudoephedrine hydrochloride	0363-9930	HYPROMELLOSE

Generic Drugs Containing GUAIFENESIN D

Company	Ingredient	NDC	Excipient
CVS Pharmacy Inc	guaifenesin and pseudoephedrine hydrochloride	51316-993	CARBOMER HOMOPOLYMER TYPE B
CVS Pharmacy Inc	guaifenesin and pseudoephedrine hydrochloride	51316-993	CELLULOSE, MICROCRYSTALLINE
CVS Pharmacy Inc	guaifenesin and pseudoephedrine hydrochloride	51316-993	HYPROMELLOSE

What are the Most Frequently-Used Excipients in GUAIFENESIN D?

# Of NDCs	Excipient
2	CARBOMER HOMOPOLYMER TYPE B
2	CELLULOSE, MICROCRYSTALLINE
2	HYPROMELLOSE

Excipient Strategy and Commercial Opportunities for Guaifenesin D

Last updated: March 6, 2026

What is the Purpose of Guaifenesin D?

Guaifenesin D combines guaifenesin with a decongestant such as pseudoephedrine or phenylephrine. It aims to treat cough, chest congestion, and nasal congestion associated with colds, flu, or allergies. The formulation typically targets over-the-counter (OTC) markets and is available as tablets, liquids, and extended-release forms.

What Are Key Excipient Strategies for Guaifenesin D?

Selection Criteria for Excipients

• Compatibility: Excipients must not chemically interact with guaifenesin or decongestants.
• Stability: Protect active ingredients from humidity, oxygen, or temperature fluctuations.
• Masking Taste: Flavoring agents, sweeteners, and bitter blockers are crucial for palatable formulations, especially liquids.
• Enhanced Delivery: Excipients can improve bioavailability or control release profiles in extended-release formulations.

Common Excipients Used

Category	Examples	Purpose
Fillers/Diluents	Microcrystalline cellulose, lactose	Bulk-forming for tablet compression
Binders	Hydroxypropyl methylcellulose, starch	Help tablet integrity
Disintegrants	Croscarmellose sodium, sodium starch glycolate	Facilitate tablet disintegration
Flavoring agents	Menthol, cherry flavor, sweeteners	Mask bitter taste, improve sensory experience
Lubricants	Magnesium stearate	Reduce friction during compression
Preservatives	Benzalkonium chloride in liquids	Extend shelf life
Stabilizers	Ascorbic acid, citric acid	Prevent oxidation of active ingredients

Advanced Excipient Strategies

• Controlled-release matrices: Use of hydrophilic polymers (e.g., hydroxypropyl methylcellulose) to modulate release rates.
• Targeted delivery: Incorporation of lipid-based excipients or nanocarriers to enhance bioavailability.
• Taste masking: Multi-layer coatings or complexation techniques to improve patient experience.

Market and Commercial Opportunities

Growing OTC Market

• The global OTC cough, cold, and allergy drugs market was valued at USD 50 billion in 2021, expected to grow at approximately 4% CAGR through 2030 [1].
• Guaifenesin-based products account for a significant share, driven by consumer demand for effective, non-prescription remedies.

Innovation and Differentiation

• Extended-release formulations: Offer convenience and compliance, allowing once-daily dosing.
• Combination products: Pairing Guaifenesin D with other APIs (e.g., antihistamines) addresses multiple symptoms.
• Flavor and sensory improvement: Developing taste-masked liquids for children expands market accessibility.

Regulatory and Market Entry Considerations

• US OTC monographs or NDA approvals influence formulation flexibility.
• Emphasis on excipient safety profiles to meet regulatory standards (e.g., FDA guidance on excipients in OTC drugs).

Patent and Legal Landscape

• Many formulations are unpatented or have expired patents. Innovators can explore novel excipient combinations, delivery mechanisms, or packaging methods to create differentiation.
• Patents on specific extended-release technologies offer licensing opportunities.

Challenges and Risks

• Regulatory scrutiny over excipient safety, especially in pediatric formulations.
• Market saturation with established guaifenesin products limits new entrants.
• Supply chain disruptions in excipient sourcing can impact manufacturing.

Key Takeaways

• Excipient strategies should prioritize compatibility, stability, taste masking, and delivery optimization.
• Advanced excipients enable formulation differentiation, especially in extended-release and combination offerings.
• The OTC cough and cold market presents steady growth; innovation in delivery and sensory profiles can boost commercial success.
• Regulatory compliance and safety profiles are critical in excipient selection, particularly in formulations for sensitive populations.
• Patent expiry on many guaifenesin products allows for formulation innovation but requires careful navigation of the legal landscape.

FAQs

Q1: What excipients are most commonly used in Guaifenesin D formulations?
Microcrystalline cellulose, lactose, hydroxypropyl methylcellulose, croscarmellose sodium, menthol, sweeteners, and magnesium stearate.

Q2: How do excipients influence the stability of Guaifenesin D?
They protect active ingredients from environmental factors like humidity, oxygen, and light, thereby extending shelf life.

Q3: What formulation approaches can improve patient adherence?
Extended-release formulations, taste-masked liquids, and combination products reduce dosing frequency and improve palatability.

Q4: Are there regulatory concerns related to excipients in Guaifenesin D?
Yes. Excipients must meet safety standards set by agencies like FDA, especially for pediatric products.

Q5: What commercial opportunities exist for innovative excipient use in Guaifenesin D?
Development of controlled-release matrices, taste-masked liquids, and combination OTC products can differentiate products and capture new market segments.

References

[1] Market Research Future. (2022). OTC Cough, Cold, and Allergy Drugs Market Report. Retrieved from https://marketresearchfuture.com/