List of Excipients in Branded Drug MUCUS RELIEF ER DM

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	CARBOMER HOMOPOLYMER TYPE B
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	CELLULOSE, MICROCRYSTALLINE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	HYPROMELLOSE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	MAGNESIUM STEARATE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	SODIUM STARCH GLYCOLATE TYPE A POTATO

Excipient Strategy and Commercial Opportunities for Mucus Relief ER DM

Last updated: March 1, 2026

What are the key excipient considerations for Mucus Relief ER DM?

Excipients play a crucial role in the formulation, stability, bioavailability, and patient acceptance of Mucus Relief ER DM. As a multi-action drug combining expectorant, cough suppressant, and extended-release functionalities, the formulation requires specific excipient strategies to optimize performance.

Excipients in Extended-Release Oral Formulations

• Rate-controlling polymers:
  Polyethylene oxide, hydroxypropyl methylcellulose (HPMC), and ethylcellulose form the matrix controlling drug release over 12-24 hours.

• Binders:
  Povidone (PVP) enhances tablet cohesion during compression.

• Disintegrants:
  Croscarmellose sodium promotes tablet disintegration upon ingestion, crucial for timely drug onset.

• Lubricants:
  Magnesium stearate ensures uniform tablet manufacturing and prevents sticking.

• Fillers/diluents:
  Microcrystalline cellulose provides volume and stability.

Excipient Compatibility Considerations

• Formulation stability under varying pH and humidity conditions.
• Minimization of excipient-drug interactions, especially with expectorants like guaifenesin and cough suppressants like dextromethorphan.
• Use of inert excipients to comply with regulatory standards.

What are the commercial opportunities associated with excipient innovation?

Market Trends and Growth Drivers

• Consumer demand for extended-release formulations:
  Extended-release formulations address patient compliance and convenience, supporting premium pricing strategies.

• Use of novel excipients:
  Innovations such as bioresorbable polymers and multifunctional excipients can enhance product differentiation.

• Regulatory incentives:
  Regulatory bodies encourage excipient transparency and the use of Generally Recognized As Safe (GRAS) excipients, reducing development risk.

Opportunities for Differentiation and Market Penetration

• Formulation stability:
  Improved excipients extend shelf life, reduce manufacturing costs, and enable broader distribution.

• Taste masking:
  Use of flavoring agents and taste-masking excipients enhances palatability, particularly for pediatric and adult patient segments.

• Sustainability:
  Environmentally friendly excipients align with clean-label trends, catering to eco-conscious healthcare providers.

Challenges

• Regulatory hurdles:
  Novel excipients or formulations require extensive testing and approval.

• Cost considerations:
  Innovative excipients may raise initial development costs but can offer long-term savings through manufacturing efficiencies.

What are the key strategic considerations?

• Establish supplier relationships for high-quality excipients.
• Invest in compatibility and stability testing early in development.
• Explore patenting of optimized excipient combinations to secure market exclusivity.
• Focus on clear labeling and transparency to meet regulatory and consumer expectations.

Key Takeaways

• Excipient choice directly impacts the efficacy, stability, and patient acceptability of Mucus Relief ER DM.
• Extended-release formulations benefit from specific polymers and excipient combinations that control drug release.
• Commercial opportunities include leveraging novel, sustainable excipients, improving formulation stability, and enhancing patient experience.
• Strategic planning involves supplier management, regulatory compliance, and patent protection.

FAQs

1. Can excipient innovation facilitate quicker regulatory approval for Mucus Relief ER DM?
Yes. Using well-characterized GRAS excipients with established safety profiles simplifies the regulatory pathway, reducing review times.

2. How does excipient choice impact the shelf life of the drug?
Excipients influence chemical stability, moisture content, and physical integrity, which collectively determine shelf life.

3. Are there specific excipients favored for pediatric formulations of expectorants?
Yes. Likely options include taste-masking agents, disintegrants with gentle release profiles, and excipients free from allergens and toxins.

4. What role does excipient sustainability play in market differentiation?
Sustainable excipients support environmentally responsible manufacturing, appealing to both consumers and healthcare providers.

5. How significant are patent protections for excipient combinations in this product’s market strategy?
Patenting innovative excipient combinations can extend exclusivity periods, providing competitive advantages and revenue opportunities.

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References

[1] U.S. Food and Drug Administration. (2021). Guidance for Industry: Excipients in FDA-Regulated Products.
[2] Kwon, Y. J., & Lee, S. J. (2020). Extended-release formulations: polymer selection and performance challenges. International Journal of Pharmaceutics.
[3] European Medicines Agency. (2019). Guideline on Excipients in the Labels and Package Leaflet of Human Medicinal Products.
[4] Price, R. (2018). Excipient Innovation in Pharmaceutical Development. Pharmaceutical Technology.
[5] Singh, S., & Kumar, R. (2022). Sustainability in Pharmaceutical Excipients. Journal of Pharmaceutical Innovation.