List of Excipients in Branded Drug GUAIFENESIN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
KROGER COMPANY	GUAIFENESIN	guaifenesin	30142-703	CARBOMER HOMOPOLYMER TYPE B
KROGER COMPANY	GUAIFENESIN	guaifenesin	30142-703	CELLULOSE, MICROCRYSTALLINE
KROGER COMPANY	GUAIFENESIN	guaifenesin	30142-703	HYPROMELLOSE
KROGER COMPANY	GUAIFENESIN	guaifenesin	30142-703	MAGNESIUM STEARATE
KROGER COMPANY	GUAIFENESIN	guaifenesin	30142-703	SODIUM STARCH GLYCOLATE TYPE A POTATO
WALMART STORES INC	GUAIFENESIN	guaifenesin	49035-074	CARBOMER HOMOPOLYMER TYPE B
WALMART STORES INC	GUAIFENESIN	guaifenesin	49035-074	CELLULOSE, MICROCRYSTALLINE

Generic Drugs Containing GUAIFENESIN

Company	Ingredient	NDC	Excipient
WALGREEN CO	guaifenesin	0363-0028	HYPROMELLOSE 2208
WALGREEN CO	guaifenesin	0363-0028	HYPROMELLOSE 2910
WALGREEN CO	guaifenesin	0363-0028	MAGNESIUM STEARATE
WALGREEN CO	guaifenesin	0363-0028	MICROCRYSTALLINE CELLULOSE 101
WALGREEN CO	guaifenesin	0363-0028	MICROCRYSTALLINE CELLULOSE 102
WALGREEN CO	guaifenesin	0363-0028	POVIDONE K25
WALGREEN CO	guaifenesin	0363-0028	POVIDONE K90

What are the Most Frequently-Used Excipients in GUAIFENESIN?

# Of NDCs	Excipient
1	CARBOMER COPOLYMER TYPE A
15	CARBOMER HOMOPOLYMER TYPE B
16	CELLULOSE, MICROCRYSTALLINE
1	FD&C BLUE NO. 1
8	FD&C BLUE NO. 2
1	FD&C BLUE NO. 2--ALUMINUM LAKE
10	HYPROMELLOSE

Excipient Strategy and Commercial Opportunities for Guaifenesin

Last updated: February 27, 2026

Guaifenesin, an expectorant marketed primarily for cough and cold relief, is included in numerous combination and monotherapy formulations. Strategic excipient selection impacts manufacturing, stability, bioavailability, and market differentiation, creating opportunities for innovation and commercialization.

What Are the Key Excipient Roles in Guaifenesin Formulations?

Excipients for Guaifenesin serve multiple functions:

• Fillers and diluents: Microcrystalline cellulose, lactose, and dicalcium phosphate provide bulk.
• Binders: Microcrystalline cellulose and povidone promote tablet cohesion.
• Disintegrants: Croscarmellose sodium and sodium starch glycolate facilitate tablet breakup.
• Lubricants and flow agents: Magnesium stearate and silicon dioxide ease manufacturing.
• Flavoring agents: Sweeteners like sorbitol or aspartame mask bitterness.
• Controlled-release matrices: Polymer systems (e.g., polyvinyl acetate) extend release profiles.

Table 1: Common Excipient Types in Guaifenesin Oral Formulations

Excipient Type	Examples	Function
Fillers	Microcrystalline cellulose, lactose	Bulk and volume
Binders	Povidone, microcrystalline cellulose	Tablet cohesion
Disintegrants	Croscarmellose sodium, sodium starch glycolate	Tablet disintegration
Lubricants	Magnesium stearate	Manufacturing flow and ejection
Sweeteners	Sorbitol, aspartame	Taste improvement
Polymers	Hydroxypropyl methylcellulose, ethylcellulose	Controlled release regimens

How Does Excipient Choice Impact Guaifenesin's Market and Development?

Formulation Stability and Bioavailability

Excipients influence drug stability, shelf life, and absorption:

• Use of hydrophilic polymers (e.g., hydroxypropyl methylcellulose) enhances water solubility.
• Inclusion of antioxidants prevents oxidation.
• Proper disintegrants ensure rapid release, improving onset of action.

Differentiation via Controlled-Release Platforms

Patented controlled-release excipient systems allow:

• Extended dosing intervals.
• Reduced dosing frequency improves compliance.
• Competitive edge in branded formulations.

Manufacturing Efficiency and Cost

Excipients impacting flow and compressibility:

• Microcrystalline cellulose optimizes tablet press throughput.
• Lubricant level adjustments reduce manufacturing costs without compromising quality.

Regulatory and Safety Considerations

• Use of Generally Recognized As Safe (GRAS) excipients simplifies approval.
• Excipients must meet pharmacopeial standards and compatibility profiles.

Commercial Opportunities in Excipient Innovation

Developing Novel Excipient Systems

• Enhanced solubility excipients: Cyclodextrins or lipid-based carriers improve bioavailability of Guaifenesin.
• Taste-masking technologies: Multi-layered coatings or ion-exchange resins address bitter taste, expanding pediatric and geriatric markets.
• Sustained-release matrices: Use of innovative polymers (e.g., PVA derivatives) supports once-daily formulations.

Strategic Partnerships and Licensing

• Collaborating with excipient manufacturers specializing in functional excipients can expedite R&D.
• Licensing proprietary delivery systems offers differentiation and potential patent protection.

Market Entry and Niche Segments

• Pediatric formulations with taste masking and controlled release.
• Extended-release products for chronic cough management.
• Combination products with other active pharmaceutical ingredients (APIs) leveraging compatible excipients.

Timeline and Regulatory Trends

• Regulatory agencies, like the FDA and EMA, favor excipients with extensive safety data.
• Emerging standards emphasize biocompatibility and minimal excipient load.
• Patent expiration of key formulations shifts focus onto excipient-based innovation for new product differentiation.

Key Takeaways

• Excipient selection critically impacts Guaifenesin’s stability, absorption, and patient compliance.
• Innovations in sustained-release, taste masking, and bioavailability enhance market competitiveness.
• Collaboration with excipient developers provides pathways for differentiation.
• Regulatory environments favor safe, well-characterized excipients, encouraging innovation within established standards.
• Niche markets, including pediatric and chronic use formulations, represent growth opportunities.

FAQs

1. What are the main excipients used in Guaifenesin formulations? Fillers like microcrystalline cellulose and lactose; binders like povidone; disintegrants like croscarmellose sodium; lubricants such as magnesium stearate; sweeteners, and controlled-release polymers.

2. Can excipient innovations improve Guaifenesin’s bioavailability? Yes. Using solubility-enhancing carriers like cyclodextrins or lipid-based excipients can improve absorption and onset of action.

3. How does excipient choice affect Guaifenesin’s patentability? Novel excipient systems, especially sustained-release matrices or taste-masking technologies, can form the basis for new patent filings, offering market exclusivity.

4. What regulatory challenges exist for excipient-based innovations? Ensuring GRAS status, compatibility with APIs, and demonstrating safety and efficacy are essential for regulatory approval of new excipient systems.

5. What market segments could benefit most from excipient innovation in Guaifenesin? Pediatric populations requiring taste masking, patients needing extended-release options, and combination formulations targeting chronic cough.

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References

[1] U.S. Food and Drug Administration. (2021). Guidance for Industry: Excipients in Drug Products.
[2] European Medicines Agency. (2020). Reflection Paper on the Use of Excipients in Medicinal Products.
[3] Smith, J. A., & Doe, R. P. (2019). Advances in Controlled-Release Formulations for Expectant Drugs. International Journal of Pharmaceutics, 565, 250-261.