Tips for: Solid Oral Dosage Forms

Minor changes in pharmaceutical formulations, including adjustments to excipient composition, particle size, or manufacturing parameters, can lead to significant variability in drug release profiles. Even small modifications, such as altering the type of binder or changing the mixing speed, can affect how quickly or slowly the active pharmaceutical ingredient (API) is released from the dosage form. This variability can result in inconsistent therapeutic outcomes, poor bioavailability, and challenges in meeting regulatory requirements. Ensuring consistent drug release is crucial for patient safety and treatment efficacy.
Click to read the full article.

Drugs with strong oxidative potential pose significant challenges during the formulation process, especially when encapsulated in soft gelatin capsules or other dosage forms. These drugs are highly susceptible to degradation due to oxidation, which can lead to a loss of efficacy, altered therapeutic activity, or the formation of harmful by-products. The oxidative instability of these drugs often requires specific handling, protective measures, and excipient selection to ensure that the drug remains stable throughout its shelf life. Additionally, the oxidative potential of the API can complicate compatibility with capsule materials, excipients, and manufacturing processes.
Click to read the full article.

The use of soft gelatin capsules and hard gelatin capsules is a common method for delivering pharmaceuticals, particularly for APIs that require solubilization or protection from the environment. However, the use of gelatin, which is derived from animal collagen, presents challenges for patients and manufacturers seeking vegetarian, vegan, or halal-certified options. The demand for shell materials free from animal origin has increased due to ethical concerns, religious requirements, and the growing trend toward plant-based and sustainable products. Despite this, the options for non-animal-derived shell materials are still limited, and their development is essential for meeting market needs without compromising capsule performance or patient acceptance.
Click to read the full article.

The encapsulation of drugs with variable particle size distribution (PSD) is a common challenge in pharmaceutical formulations, especially when preparing capsules for solid oral dosage forms. The size and uniformity of the particles in the drug mixture directly affect the fill weight, disintegration time, dissolution rate, and overall performance of the final product. A variable particle size distribution can lead to issues such as inconsistent dosing, poor flow properties, difficulty in achieving the correct fill weight, and variation in drug release profiles. Addressing these issues requires careful optimization of the formulation, excipient selection, and encapsulation process.
Click to read the full article.

Lipid-based excipients, such as oils, fats, and lipids, play a critical role in the formulation of soft gelatin capsules, particularly for hydrophobic active pharmaceutical ingredients (APIs). These excipients help to solubilize poorly soluble drugs, enhance bioavailability, and provide stability in the final dosage form. However, the lack of standardization in lipid-based excipient formulations can create challenges in ensuring consistent product quality, reproducibility, and regulatory compliance. Variability in excipient composition, source, and processing can lead to inconsistent performance, affecting the dissolution, stability, and efficacy of the final product.
Click to read the full article.

The disintegration time of soft gelatin capsules plays a crucial role in ensuring that the drug is released effectively and absorbed into the body. A faster disintegration rate is particularly important for drugs that require rapid onset of action. However, optimizing the shell composition to achieve the desired disintegration time while maintaining capsule stability and integrity is a significant challenge. Factors such as the type of gelatin used, the presence of plasticizers, and the formulation of the fill material all influence the disintegration behavior of the capsule. Achieving the right balance between these components is essential for improving bioavailability without compromising the stability of the final product.
Click to read the full article.

Encapsulating oils in soft gelatin capsules is a common practice for delivering lipophilic active pharmaceutical ingredients (APIs) in a convenient oral dosage form. However, oils with high peroxide content present a unique challenge. Peroxides, which form during the oxidation of oils, are unstable and can cause degradation of both the API and the capsule itself. The presence of peroxides in oils can lead to reduced efficacy of the drug, potential side effects, and compromised product stability. Therefore, managing peroxide content in oils used for encapsulation is crucial for ensuring the safety and effectiveness of soft gelatin capsules.
Click to read the full article.