Tips for: Solid Oral Dosage Forms

Pediatric patients present unique challenges in pharmaceutical formulation, particularly when it comes to capsule dosage forms. Children often have different pharmacokinetic profiles, swallowing abilities, and taste preferences compared to adults, making it difficult to design effective and acceptable dosage forms. Hard gelatin capsules and soft gelatin capsules, which are commonly used for adult formulations, may not be suitable for pediatric use due to size, taste, and ease of administration concerns. Moreover, the need for accurate dosing, safety, and palatability complicates the development process for pediatric capsules.
Click to read the full article.

Site-specific drug release is a challenging but critical aspect of pharmaceutical formulation, especially for drugs that require targeted delivery to specific regions of the gastrointestinal tract or other targeted areas of the body. The complexity of designing such formulations arises from the need to overcome physiological barriers such as varying pH levels, enzymatic activity, and gastric emptying times. Achieving site-specific release often requires the use of sophisticated drug delivery systems that can release the API in a controlled and predictable manner at the intended site. This involves intricate formulation strategies that must balance drug solubility, stability, and bioavailability, while also ensuring safety and efficacy.
Click to read the full article.

Capsule weight gain during stability studies is a significant challenge in the pharmaceutical industry, particularly for soft gelatin capsules and liquid-filled capsules. This issue arises when the capsule shell absorbs moisture or other environmental elements during storage, leading to an increase in weight. The weight gain can be caused by factors such as humidity, temperature fluctuations, and the permeability of the capsule material. This problem can compromise the stability, safety, and efficacy of the product, as the weight gain can alter the dissolution rate, drug release profile, and the capsule’s overall integrity, potentially impacting regulatory compliance and market acceptance.
Click to read the full article.

Hard gelatin capsules are commonly used for drug delivery, but when the active pharmaceutical ingredient (API) is acid-sensitive, compatibility with the gelatin shell becomes a challenge. Acid-sensitive APIs may degrade or lose efficacy when exposed to acidic conditions, such as those found in the stomach. This is particularly problematic in hard gelatin capsules, as the gelatin shell dissolves in the stomach’s acidic environment, potentially exposing the API to degradation before it reaches its intended site of action. For such drugs, formulations that protect the API from stomach acid are essential to ensure therapeutic efficacy and patient safety.
Click to read the full article.

Hygroscopic ingredients, such as certain excipients or active pharmaceutical ingredients (APIs), are prone to absorbing moisture from the surrounding environment. This moisture absorption can cause the weight and volume of these ingredients to change, leading to inconsistencies in the fill weight of capsules. These variations can result in inaccurate dosing, affecting the efficacy, safety, and quality of the final product. In the case of hard gelatin or soft gelatin capsules, achieving consistent fill weight is crucial for meeting regulatory requirements and ensuring therapeutic effectiveness. Addressing the challenges posed by hygroscopic ingredients is key to ensuring uniformity in capsule formulations.
Click to read the full article.

Hard gelatin capsules are widely used for oral drug delivery, but achieving a rapid onset of action in these capsules can be challenging. For certain drugs, the speed at which the API is released and absorbed into the bloodstream is crucial for therapeutic efficacy, especially for acute conditions where immediate relief is needed. However, the physical properties of hard gelatin capsules, such as their dissolution rate and the rate at which the API is released, can affect the onset of action. Inadequate formulation or capsule design can lead to slow dissolution or incomplete absorption, delaying the drug’s effects and reducing its clinical effectiveness.
Click to read the full article.

Aqueous-based formulations, such as those used in soft gelatin capsules containing suspensions, emulsions, or liquid-filled capsules, face significant challenges with microbial contamination. Due to the high moisture content in these formulations, they provide an ideal environment for microbial growth if not properly controlled. Microbial contamination can lead to product spoilage, reduced shelf life, and potential health risks to patients. In addition, regulatory agencies such as the FDA and EMA require strict controls over microbial contamination in pharmaceutical products, making it essential for manufacturers to implement effective strategies to prevent contamination during formulation, filling, and storage.
Click to read the full article.