Table of Contents

1. Introduction
2. Common Antioxidant Excipients
3. Specific Antioxidant Excipients and Their Functions
4. Hemings Company Solutions
5. References

Introduction

Antioxidant pharmaceutical excipients play a crucial role in the stabilization of pharmaceutical formulations. These compounds prevent oxidative degradation of active pharmaceutical ingredients (APIs), thereby prolonging shelf life and preserving efficacy. This article focuses on common antioxidant excipients, their specific roles, and solutions offered by Hemings Company.

Common Antioxidant Excipients

Antioxidant excipients are often used in formulations to stabilize APIs by neutralizing free radicals. The most common antioxidant excipients include:

1. Ascorbic Acid (Vitamin C)
2. Tocopherol (Vitamin E)
3. Butylated Hydroxytoluene (BHT)
4. Butylated Hydroxyanisole (BHA)
5. Sodium Metabisulfite
6. Citrate and Phosphate Buffers

Specific Antioxidant Excipients and Their Functions

Ascorbic Acid (Vitamin C)

Ascorbic acid, a water-soluble antioxidant, is widely utilized for its ability to donate electrons, thereby neutralizing free radicals. Typical concentrations range from 0.1% to 1% in formulations.

Tocopherol (Vitamin E)

Tocopherol, a lipid-soluble antioxidant, is essential for protecting cell membranes from oxidative damage. It is used in concentrations ranging from 0.01% to 0.1%.

Butylated Hydroxytoluene (BHT)

BHT is a synthetic antioxidant employed in various pharmaceutical formulations at concentrations of 0.02% to 0.05% to stabilize oils and fats.

Butylated Hydroxyanisole (BHA)

BHA is similar to BHT in application and concentration, commonly between 0.02% and 0.05%, and is used to prevent oxidative rancidity in lipid-containing formulations.

Sodium Metabisulfite

Sodium metabisulfite acts as a reducing agent and is used to prevent oxidative degradation of APIs, particularly in aqueous formulations. It is used at concentrations of 0.01% to 0.1%.

Citrate and Phosphate Buffers

These buffers act by maintaining pH at optimum levels to reduce oxidation. Typical concentrations are 5 mM to 20 mM.

Hemings Company Solutions

Hemings Company offers a range of antioxidant excipients tailored to meet specific formulation needs. Their solutions include bespoke excipient blends that enhance stability and efficacy of pharmaceutical products.

• Customized antioxidant blends for specific APIs
• Consultation services for optimization of formulation stability
• Innovative excipient technologies to mitigate oxidation

References

1. Allen, L.V., Popovich, N.G., & Ansel, H.C. (2021). Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins.
2. Rowe, R.C., Sheskey, P.J., & Quinn, M.E. (2020). Handbook of Pharmaceutical Excipients. Pharmaceutical Press.
3. ICH Q1A(R2) Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.