Lily, an 18-year-old patient, has recently been prescribed Venlafaxine Extended-Release Capsules to address her symptoms of anxiety. Lily is facing challenges when it comes to swallowing these capsules due to their size and finds herself at a loss on how to proceed. Despite her attempts to find a solution, she is unsuccessful. Lily ultimately decides to visit the pharmacy, hoping to gain clarity and guidance.
In the ever-evolving realm of pharmaceuticals, continuous strides are being made to enhance drug delivery, patient adherence, and overall treatment efficacy. Refinements to oral dosage forms, such as tablets and capsules, present tailored solutions to address diverse patient needs. However, when these modifications are not executed properly, they can lead to dire consequences that may compromise patient safety and treatment effectiveness.
The delicate balance of pharmaceutical formulation
Oral medication administration is an intricately designed process to precisely deliver therapeutic agents to the body. The ability to modify an oral dosage form depends on various factors including the medication’s chemical properties, the tablet or capsule’s formulation, and patient requirements. Modifying dosage forms can be advantageous for patients struggling with swallowing whole tablets or capsules, those who require precise dosage adjustments, or patients with unique medical needs/conditions. However, it is imperative to note that improper alterations may lead to unintended consequences.
Tablets: Crush or Split?
The practice of crushing tablets is often employed to facilitate administration, particularly for patients who have difficulty swallowing. However, not all tablets can be crushed. Tablets formulated for immediate release (IR) are generally more suitable for crushing as they are designed to be disintegrated and released quickly upon ingestion. Conversely, drugs with special formulations such as extended-release (ER, XR, XL), sustained-release (SR), controlled-release (CR), enteric-coated (EC) tablets, and dissolvable tablets should not be crushed. Such actions could alter the intended drug release profile, potentially inducing dose dumping (i.e., a large amount of drug was quickly released into our body’s circulation) and adverse effects. Additionally, medications that are considered hazardous (https://hospitalnews.com/hazardous-and-cytotoxic-drugs-safety-considerations/) or have a narrow therapeutic window (i.e., the dosage range of a medication between its minimum effective therapeutic concentration and its minimum toxic concentration is very narrow) should also be spared from crushing, as doing so may lead to unpredictable and potentially dangerous fluctuations in drug absorption (A), distribution (D), metabolism (M), excretion (E), and overall drug safety and efficacy.
In the ever-evolving realm of pharmaceuticals, continuous strides are being made to enhance drug delivery, patient adherence, and overall treatment efficacy.
Tablet splitting allows for dosage adjustments, particularly when a lower dose is required. Tablets with a score line, indicating their suitability for splitting, are generally safer for such purposes. Ensuring even splits is essential for precise dosing. Similar to crushing, ER, SR, CR or EC tablets should not be split, given the potential compromise to therapeutic efficacy and safety of the medication. Nevertheless, exceptions do exist; and there are oral dosage forms that are scored and amenable to splitting, but not crushing. Patients are advised to check with your pharmacist before doing so.
Other factors to consider (prior to crushing or splitting) are film-coating and taste. Splitting or crushing film-coated tablets could compromise drug integrity due to exposure to light, moisture, and air. Furthermore, this may expose patients to the medication’s full taste, which might be unpleasant or bitter.
Capsules: Open or not?
Hard gelatin capsules often encapsulate powders or small granules of medication. In some cases, these capsules can be opened, and their contents can be sprinkled onto soft foods or directly consumed for easier ingestion. However, this should be approached cautiously, as consuming the entire contents of the capsule is vital to obtaining the full therapeutic dose. Soft gelatin capsules that contain liquid or semi-solid formulations are typically not designed to be opened, as doing so may expose the contents to air and moisture, potentially compromising drug safety and efficacy.
How can we help Lily?
Venlafaxine Extended-Release Capsule is supplied as a hard gelatin capsule filled with pellets. Therefore, these capsules may be carefully opened, and the entire contents can be sprinkled onto soft food, such as applesauce, and swallowed
completely.
Importance of Healthcare Professional Involvement
Inappropriate modifications of oral dosage forms may result in several complications, ranging from altered drug release, drug degradation, inconsistent dosing, and altered the A-D-M-E of a medication and overall drug safety and efficacy. Healthcare professionals are pivotal in mitigating these risks by assessing each patient’s medical history, conditions, and preferences before recommending any modification. Their guidance extends to recommending appropriate modification methods, ensuring patients follow safe practices that would preserve drug efficacy and safety. There are several resources that can be consulted to determine which modifications, if any, would be appropriate. For example:
• Drug product monographs (available at the Health Canada Drug Product Database: https://health-products.canada.ca/dpd-bdpp/)
• Compendium of Pharmaceuticals and Specialties (CPS: Drug Information) (available at https://www.pharmacists.ca/products-services/cps-print/)
• Hospital drug formularies
Modifying oral dosage forms to meet patient needs is a delicate and complex process that requires a deep understanding of pharmaceutical science, drug properties, and patient considerations. While some tablets may be crushed or split, and certain capsules may be opened, these actions should always be taken under the guidance of healthcare professionals. Safety, efficacy, and patient well-being remain paramount when exploring modifications of oral dosage forms. Consulting healthcare providers and referring to reliable sources is essential to making informed decisions that support patient safety and optimal treatment outcomes.
By Karnie Garabedian, Pamela Molina, Sanaz M. Chenani, and Certina Ho
Karnie Garabedian, Pamela Molina, and Sanaz M. Chenani are PharmD Students at the Leslie Dan Faculty of Pharmacy, University of Toronto; and Certina Ho is an Assistant Professor at the Department of Psychiatry and Leslie Dan Faculty of Pharmacy, University of Toronto.
