Last updated: February 27, 2026
What is the formulation composition of Berkley and Jensen All Day Allergy?
Berkley and Jensen All Day Allergy typically contains active ingredients such as diphenhydramine hydrochloride, a first-generation antihistamine. The formulation commonly includes excipients like microcrystalline cellulose, magnesium stearate, silicon dioxide, and artificial coloring agents. The excipient profile supports tablet stability, bioavailability, and consumer acceptance.
How are excipients selected for this medication?
Excipients play multifaceted roles: enhancing stability, enabling manufacturing, controlling release, and improving patient tolerability. Selection criteria consider:
- Compatibility with active ingredients
- Regulatory approval status
- Cost-effectiveness
- Sensory attributes and packaging considerations
The excipient mixture aims to optimize shelf stability, ease of swallowing, and minimize adverse reactions.
What are strategic considerations for excipient choices?
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Regulatory Compliance: Using excipients with established safety profiles aligned with FDA and EMA guidelines.
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Supply Chain Stability: Choosing excipients with reliable sources and minimal geopolitical risks.
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Formulation Optimization: Utilizing excipients that support extended shelf life and consistent dissolution profiles.
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Market Acceptance: Incorporating excipients that reduce adverse effects like dry mouth or drowsiness, improving patient compliance.
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Cost Management: Balancing high-quality excipients with cost constraints to maintain profitability.
What are the commercial opportunities tied to excipient strategy?
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Differentiated Formulations: Developing versions with optimized excipients to reduce side effects (e.g., formulations with non-drowsy characteristics) can expand consumer segments.
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Enhanced Shelf Life: Selecting excipients that extend stability reduces wastage and distribution costs, improving margins.
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Regulatory Exclusivity: Proprietary excipient combinations may lead to formulation patents, preventing generic competition for a period.
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Custom Packaging and Delivery Formats: Exploring alternative delivery systems like orally disintegrating tablets or film strips with excipients that facilitate fast dissolution.
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Contract Manufacturing: Supplying high-quality excipients to third-party formulators for similar allergy medications generates revenue streams.
How do excipient choices impact regulatory filings and patentability?
Regulatory agencies require detailed disclosure of excipient sources, purity, and compatibility data. Patentability can hinge on unique excipient combinations or novel use of excipients, providing a competitive edge. Strategic limitations of known excipients can push developers toward patenting innovative formulations or delivery systems.
Are there emerging trends influencing excipient strategy?
Yes. Trends include:
- Use of alternative, natural excipients to meet demand for organic or clean-label products.
- Incorporation of solubilizers and permeability enhancers to improve API absorption.
- Focus on excipients with dual functionality, such as stabilizers that also act as taste-masking agents.
Summary Table: Excipient Characteristics and Opportunities
| Excipient Type |
Role |
Commercial Opportunity |
| Microcrystalline Cellulose |
Filler and binder |
Standardized, cost-effective, patent potential |
| Magnesium Stearate |
Lubricant |
Widely used, stable, potential for proprietary blends |
| Silicon Dioxide |
Glidant |
Improves flow, supports high-speed manufacturing |
| Artificial Coloring |
Aesthetic appeal |
Market differentiation, consumer preference |
What are the key considerations for future development?
- Innovate with excipients that promote faster onset or longer duration.
- Leverage natural or plant-based excipients for differentiation.
- Develop proprietary blends to extend patent protection.
- Ensure compliance with evolving regulatory standards regarding excipient safety.
Key Takeaways
- The excipient profile in Berkley and Jensen All Day Allergy is crucial for stability, manufacturability, and consumer acceptance.
- Strategic selection involves regulatory compliance, cost, supply chain stability, and market differentiation.
- Opportunities include formulation enhancements, patent development, and alternative delivery systems.
- Emerging trends focus on natural excipients, multifaceted excipients, and innovative delivery formats.
- Regulatory and patent considerations influence excipient choices and development strategies.
FAQs
1. How do excipients affect bioavailability in allergy medications?
Excipients influence drug release and dissolution, which in turn affect absorption and overall bioavailability.
2. Can modifying excipients extend the shelf life of Allergies medication?
Yes. Proper stabilizers and antioxidant excipients can prevent degradation, extending shelf life.
3. Are natural excipients viable for allergy medication formulations?
Yes. Natural excipients are increasingly preferred for consumer appeal but must meet safety, stability, and regulatory standards.
4. How does patenting relate to excipient choices?
Novel excipient combinations or uses can serve as patentable elements, providing market exclusivity.
5. What supply considerations affect excipient strategy?
Reliable sourcing, consistent quality, and cost stability are key to maintaining manufacturing efficiency.
References
[1] U.S. Food and Drug Administration (FDA). (2021). Inactive Ingredient Database. https://www.fda.gov/drugs/pharmaceutical-quality-resources/inactive-ingredients-database
[2] European Medicines Agency (EMA). (2020). Guideline on Excipients in the Labeling and Package Leaflet of Medicinal Products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-labeling-package-leaflet-medicinal-products_en.pdf
[3] Kramer, J., & Kitchen, D. (2019). Formulation strategies for allergy medications. Journal of Pharmaceutical Sciences, 108(6), 1840-1851.
[4] Kamat, R. (2020). Natural excipients in pharmaceutical formulations. International Journal of Pharmaceutical Sciences and Research, 11(4), 1700-1708.
