List of Excipients in Branded Drug CODEINE SULFATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Hikma Pharmaceuticals USA Inc	CODEINE SULFATE	codeine sulfate	0054-0243	CELLULOSE, MICROCRYSTALLINE
Hikma Pharmaceuticals USA Inc	CODEINE SULFATE	codeine sulfate	0054-0243	SILICON DIOXIDE
Hikma Pharmaceuticals USA Inc	CODEINE SULFATE	codeine sulfate	0054-0243	STARCH, CORN
Hikma Pharmaceuticals USA Inc	CODEINE SULFATE	codeine sulfate	0054-0243	STEARIC ACID
Physicians Total Care Inc	CODEINE SULFATE	codeine sulfate	54868-2541	CELLULOSE, MICROCRYSTALLINE

Generic Drugs Containing CODEINE SULFATE

Company	Ingredient	NDC	Excipient
Lannett Company Inc	codeine sulfate	0527-1698	CELLULOSE, MICROCRYSTALLINE
Lannett Company Inc	codeine sulfate	0527-1698	MAGNESIUM STEARATE
Lannett Company Inc	codeine sulfate	0527-1698	SILICON DIOXIDE
Lannett Company Inc	codeine sulfate	0527-1698	STEARIC ACID
Lannett Company Inc	codeine sulfate	0527-1698	TALC

What are the Most Frequently-Used Excipients in CODEINE SULFATE?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	MAGNESIUM STEARATE
1	SILICON DIOXIDE
1	STEARIC ACID
1	TALC

Excipient Strategy and Commercial Opportunities for Codeine Sulfate

Last updated: February 25, 2026

What is the role of excipient strategy in the formulation of codeine sulfate?

Excipient strategy involves selecting inert ingredients that stabilize, enhance bioavailability, or improve the manufacturability of codeine sulfate. The primary goal is to ensure drug stability, compliance with regulatory standards, and optimal bioavailability. Excipients used with codeine sulfate include fillers (lactose, microcrystalline cellulose), disintegrants (croscarmellose sodium), binders (povidone), coatings (hydroxypropyl methylcellulose), and flavoring agents. The selection depends on the dosage form—tablets, liquids, or formulations for controlled release.

How do excipients influence formulation choices for codeine sulfate?

• Solubility Enhancement: Codeine sulfate is poorly water-soluble; surfactants or solubilizers can improve dissolution rates.
• Stability: Stabilizers such as antioxidants prevent degradation, especially in liquid forms.
• Taste Masking: Flavors and sweeteners are incorporated to mask bitterness, especially in syrups.
• Controlling Release: Matrix-forming agents, like hydroxypropyl methylcellulose, enable controlled-release formulations, expanding therapeutic options.

What are the commercial implications of excipient selection in codeine sulfate products?

Choosing suitable excipients affects manufacturing efficiency, shelf-life, regulatory approval, and consumer acceptance. The global market favors formulations that are stable, palatable, and have predictable pharmacokinetics.

Market trends:

• Extended-release formulations: Use of specific excipients allows for once-daily dosing, increasing patient compliance.
• Liquid formulations: Require stabilizers, flavorings, and preservatives, creating opportunities in pediatric and geriatric markets.
• Combining with other active ingredients: Excipients that prevent interactions or stabilize multiple drugs open pathways for combination products.

Regulatory considerations:

• Regulatory agencies (FDA, EMA) scrutinize excipient purity, safety, and interactions.
• Emphasizing excipients with established safety profiles accelerates approval.

What are key opportunities based on excipient strategies for future growth?

• Development of abuse-deterrent formulations: Incorporating excipients that hinder tampering to reduce abuse potential.
• Innovative controlled-release systems: Using novel polymers and matrices to prolong action, expanding indications.
• Pediatric and geriatric formulations: Utilizing excipients that ensure safety and compliance for sensitive populations.
• Combination therapies: Formulating codeine sulfate with other analgesics using compatible excipients to address multi-modal pain management.

How does excipient innovation impact the competitive landscape?

Suppliers' ability to provide high-quality, regulatory-compliant excipients tailored to codeine sulfate formulations gives manufacturers competitive advantages. Early adoption of excipients that enable novel delivery systems can lead to patent extensions and differentiated products.

Summary table: Excipient considerations for codeine sulfate formulations

Aspect	Key Factors	Examples of Excipients	Implications
Solubility	Improve dissolution rates	Surfactants, cyclodextrins	Enhances bioavailability and efficacy
Stability	Extend shelf life, prevent degradation	Antioxidants, stabilizers	Regulatory compliance, consumer safety
Taste and compliance	Mask bitterness, improve palatability	Sweeteners, flavorings	Market acceptance, patient adherence
Controlled release	Prolong duration, reduce dosing frequency	Hydroxypropyl methylcellulose, ethylcellulose	Increased convenience, market differentiation

Key takeaways

• Excipients govern the stability, bioavailability, and patient acceptance of codeine sulfate products.
• Formulation strategies must align with regulatory standards to accelerate market approval.
• Market opportunities include controlled-release, abuse-deterrent, and specialized formulations for vulnerable populations.
• Supplier innovation and regulatory compliance are vital for competitive advantage.

FAQs

1. How do excipients influence the bioavailability of codeine sulfate?

Excipients such as surfactants or cyclodextrins increase solubility and dissolution, improving absorption and therapeutic efficacy.

2. What excipients are common in liquid formulations of codeine sulfate?

Preservatives (e.g., sodium benzoate), flavoring agents (e.g., cherry flavor), sweeteners (e.g., sucrose), stabilizers (e.g., antioxidants).

3. Are there safety concerns related to excipients in codeine sulfate formulations?

Regulatory agencies limit certain excipients in pediatric or sensitive populations. Excipients must meet purity and safety standards.

4. How can excipient innovation create new market opportunities for codeine sulfate?

Novel excipients enable controlled-release, combination products, and abuse-deterrent formulations, expanding therapeutic options.

5. What regulatory challenges exist with excipients?

Regulators require detailed safety data, compatibility studies, and manufacturing controls. Novel excipients may need additional approval pathways.

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References

[1] U.S. Food and Drug Administration. (2020). Guidance for Industry: Excipients in Drug Product Labeling. FDA.
[2] European Medicines Agency. (2022). Guideline on excipients in the label and leaflets of medicinal products. EMA.
[3] Katzung, B. G., Masters, S. B., & Trevor, A. J. (2012). Basic & Clinical Pharmacology (12th ed.). McGraw-Hill.