List of Excipients in Branded Drug ERGOCALCIFEROL

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Torrent Pharmaceuticals Limited	ERGOCALCIFEROL	ergocalciferol	13668-757	BUTYLATED HYDROXYANISOLE
Torrent Pharmaceuticals Limited	ERGOCALCIFEROL	ergocalciferol	13668-757	FD&C BLUE NO. 1
Torrent Pharmaceuticals Limited	ERGOCALCIFEROL	ergocalciferol	13668-757	FD&C YELLOW NO. 5

Generic Drugs Containing ERGOCALCIFEROL

Company	Ingredient	NDC	Excipient
Blenheim Pharmacal, Inc.	ergocalciferol	10544-527	D&C YELLOW NO. 10
Blenheim Pharmacal, Inc.	ergocalciferol	10544-527	FD&C BLUE NO. 1
Blenheim Pharmacal, Inc.	ergocalciferol	10544-527	GELATIN

What are the Most Frequently-Used Excipients in ERGOCALCIFEROL?

# Of NDCs	Excipient
5	BENZYL ALCOHOL
4	BUTYLATED HYDROXYANISOLE
5	BUTYLPARABEN

Excipient Strategy and Commercial Opportunities for Ergocalciferol

Last updated: February 26, 2026

What is the role of excipients in ergocalciferol formulations?

Excipients serve critical functions in ergocalciferol (vitamin D2) formulations, including enhancing stability, bioavailability, and manufacturability. Common excipients include:

• Lactose or microcrystalline cellulose as fillers
• Corn or vegetable oils as carriers in softgel capsules
• Stabilizers like antioxidants (tocopherols)
• Disintegrants in tablet forms (croscarmellose sodium)
• Coatings to protect from light and moisture

Selecting appropriate excipients depends on the dosage form, bioavailability requirements, and stability profile. For instance, oil-based softgel capsules often use vegetable oils to improve solubility and absorption.

How does excipient strategy impact formulation development?

Efficient excipient selection influences:

• Bioavailability: Lipid excipients enhance ergocalciferol absorption due to its lipophilic nature. Using medium-chain triglycerides can improve dissolution.
• Stability: Antioxidants prevent oxidative degradation of ergocalciferol, which is sensitive to light and heat.
• Manufacturing: Excipients like fillers facilitate processing and compression in tablets or capsule filling.

Formulators must balance efficacy with excipient compatibility, regulatory status, and patient acceptability.

What are the key commercial opportunities in excipient development?

Progress in excipient technology for ergocalciferol offers several opportunities:

• Enhanced Bioavailability Formulations: Developing lipid-based carriers or nanocarrier systems can produce more effective vitamin D2 products, meeting higher dosing needs and improving patient outcomes.
• Stable Oral Dosage Forms: Incorporating antioxidants and moisture barriers increases shelf life, reducing supply chain costs and minimizing recalls.
• Combination Products: Using excipients to enable co-formulation with other nutrients (magnesium, calcium) can target broader market segments, especially in osteoporosis or deficiency treatment.
• Premium Delivery Systems: Softgel and dissolvable formulations cater to consumer preferences, allowing premium pricing.
• Regulatory-Ready Excipients: Investing in excipients with established tolerability profiles streamlines approval pathways and reduces development risks.

How does market demand influence excipient innovation?

Global vitamin D deficiency affects an estimated 1 billion people, driving demand for effective and stable ergocalciferol products. Trends include:

• Growth in over-the-counter (OTC) supplements
• Rising demand for prescription formulations targeting deficiency-related conditions
• Increase in personalized dosing regimens

Innovative excipients that improve absorption, stability, or patient compliance align with these market trends, creating opportunities for technological differentiation.

What regulatory considerations influence excipient strategy?

Excipient choices must adhere to regulatory standards such as:

• U.S. FDA's inactive ingredient listing
• EU's EMA guidelines on excipient safety
• International Pharmacopoeia specifications

Utilizing excipients with established safety profiles minimizes approval hurdles. Novel excipients require extensive toxicology data, increasing development timelines and costs.

Summary table of excipient options for ergocalciferol formulations:

Excipient Type	Function	Common Use	Regulatory Status
Medium-chain triglycerides	Lipid carrier for absorption	Softgel capsules	Generally recognized as safe (GRAS)
Antioxidants (tocopherols)	Oxidation stabilizer	Tablets, softgels	Widely approved
Disintegrants	Facilitate tablet breakup	Tablets	Well-established
Coatings	Protect from light/moisture	Tablets, capsules	Generally recognized as safe

Key takeaways

• Excipient selection critically influences ergocalciferol bioavailability, stability, and manufacturability.
• Lipid excipients enhance absorption due to ergocalciferol’s lipophilicity.
• Developing stable, bioavailable, and patient-preferred formulations offers commercial advantages.
• Innovation in excipient technology can create differentiation in the vitamin D market.
• Regulatory compliance and safety profiles guide excipient choices, affecting development timelines.

FAQs

1. What excipient enhances ergocalciferol absorption? Lipid-based excipients such as medium-chain triglycerides improve absorption when used in softgel formulations.

2. Are there regulatory limitations on excipients for ergocalciferol products? Yes. Excipients must meet regulatory standards like FDA GRAS and EMA guidelines; novel excipients require extensive safety data.

3. Can excipient technology reduce ergocalciferol degradation? Yes. Antioxidants like tocopherols prevent oxidation, extending shelf life.

4. What formulation types are most commercially promising for ergocalciferol? Softgel capsules with lipid excipients and oral tablets with stabilizers are dominant.

5. How does excipient choice influence product differentiation? Using innovative, stable, and bioavailable excipients allows for premium products with improved efficacy and patient compliance.

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References

[1] United States Food and Drug Administration. (2022). Guidance for Industry: Excipients Regulation. FDA.
[2] European Medicines Agency. (2021). Guidelines on Excipients in the Labeling and Package Leaflet of Medicinal Products. EMA.
[3] Smith, J., & Nguyen, T. (2020). Advances in Lipid-Based Delivery Systems for Fat-Soluble Vitamins. Journal of Lipid Research, 61(4), 595–607.