CELLETS® 150-300 – a size of a sphere
In the realm of pharmaceutical formulations, the quest for efficient and reliable drug delivery systems has led to significant advancements. Among these, CELLETS®—highly spherical microcrystalline cellulose (MCC) pellets—have emerged as a pivotal component in developing multiparticulate dosage forms for oral applications. These neutral starter cores offer a versatile platform for active pharmaceutical ingredient (API) layering and coating, enabling controlled and sustained release profiles.
Understanding Pellet Technologies
Pellet technologies refer to the process of utilizing starter pellets as excipients in pharmaceutical formulations. These pellets serve as carriers for APIs and excipients, facilitating the creation of modern drug formulations with defined drug release profiles or taste-masking properties. The process involves coating and layering APIs onto these starter spheres, resulting in formulations that can offer various therapeutic benefits and balancing the demand for patience compliances. Thereby, the pellet size is of crucial interest for the final dosage form.
Thus, pellet technology is the admission ticket onto the stage of multiparticulate dosage forms. In the following, let’s shed some light on the intriguing benefits of these modern formulation’s attempts.
Advantages of Multiparticulate Dosage Forms
Multiparticulate dosage forms, such as those employing CELLETS®, present several advantages over traditional monolithic systems:
- Enhanced Safety: The distribution of APIs across multiple pellets reduces the risk of localized high drug concentrations in the gastrointestinal tract, minimizing potential side effects, such as risk of sudden dose dumping or the variability of gastric emptying.
- Improved Compliance: Controlled release profiles can lead to reduced dosing frequency, enhancing patient adherence to medication regimens. This might also include simplification on drug uptake as it lowers the dependency on the nutrition state.
- Flexible Formulation: The ability to combine pellets with different release characteristics allows for tailored therapeutic outcomes, addressing specific patient needs. Thus, a suitable formulation allows high control on time and place of drug delivery.
Advancements in CELLETS® for Pharmaceutical Formulations
CELLETS® have undergone continuous development to meet the evolving demands of pharmaceutical formulations:
- Chemical Inertness: Composed of 100% microcrystalline cellulose, CELLETS® are chemically inert, ensuring no interaction with APIs, which preserves the stability and efficacy of the drug. Another aspect of chemical inertness is a favorable handling for patients with metabolic disorder: the nutritional table of MCC does not any protein, fat, carbohydrate, sugar or salt.
- Mechanical Stability: The specific manufacturing process imparts high mechanical stability to CELLETS®, characterized by low friability. This robustness facilitates efficient layering and coating processes, improving production yields.
- High Sphericity and Smooth Surface: The uniform spherical shape and smooth surface of CELLETS® enable consistent coating applications, resulting in predictable and reproducible drug release profiles.
Clearly, the almost infinite variety of pharmaceutical formulations, drug release profiles and applicant targeted benefits require flexibility at the very first point of decision: which pellet size suits best? Answer: it depends. Consequently, suppliers of pharmaceutical pellets offer a portfolio of different pellet sizes.
A bunch of sizes
CELLETS® are available in various size fractions to cater to specific formulation requirements. Technical specifications range from 100 µm for CELLETS® 100 to 1000 µm and larger for CELLETS® 1000.
Small pellets suitable for formulations requiring a balance between surface area and pellet size, facilitating controlled drug release. These tiny pellets are frequently used in formulations based on jellies, gels, or multiple unit particle systems (MUPS). While large pellet sizes above 700 µm are preferred in formulations where a larger pellet size is advantageous, such as in specific controlled-release profiles or when a higher payload of API is required. Large-sized pellets are employed in capsules or straws, just to name two applications. Mid-sized pellets represent the major class of pellet sizes, and a dedicated dosage form can not be addresses in a general statement.
If might be of importance, that a decrease in pellet size yields a higher surface-volume ratio in the formulation. The formulation expert is aware of this fact and adjusts the available drug layering surface in a single dosage unit in a way to take best benefits for the desired drug release profile. Main pellet suppliers, such as IPC Process Center (Dresden/Germany), identified this demand and offers various pellet sizes in wide and narrow particle size distributions.
Within the class of mid-sized pellets, ingredientpharm is introducing an additional pellet type, covering a size range from 150 µm to 300 µm. Size specifications are based on laser diffraction methods, which are worldwide recognized and accepted. D-values are defined as (D10/D50/D90): NLT 170 / 205-275 / NMT 295.
CELLETS® 150-300
- Particle Size: 150–300 µm. Camsizer (D10/D50/D90): NLT 170 / 205-275 / NMT 295
- Composition: 100% microcrystalline cellulose
- Appearance: White to off-white, hard, and nearly spherical particles
- Applications: Ideal for extended-release formulations of highly active or low-concentration APIs, serving as neutral starter cores and multiparticulate carriers.
Conclusion
The integration of CELLETS® into pharmaceutical formulations exemplifies the strides made in pellet technologies. The unique physicochemical properties, including chemical inertness, mechanical stability, and precise size distribution, make MCC pellets indispensable in developing safe, effective, and patient-friendly drug delivery systems. As the pharmaceutical markets continue to evolve, CELLETS® stand out as a reliable foundation for innovative dosage forms. With the new type CELLETS® 150-300, a remarkable particle size is now available which experts for modern extended-release formulations had been waiting for.
Source: ingredientpharm, website Cellets formulation, https://cellets.com/