Did you know about minitablets?

Designing a dosage form that is patient-focused can be helped by a multi particulate formulation technique. Minitablets, which are compressed tablets with typical dimensions of one to four millimetres, are one such dosage type. Minitablets can be used in a variety of situations, such as paediatric dosage forms, for patients with dysphagia, and in situations requiring quick or flexible dose modifications. Orally disintegrating tablets (ODTs), extended release formulations, and gastrointestinal-targeted delivery are a few examples of functions that can be achieved through modifications to tablet formulation and coating systems. The manufacturing processes used to create dosage forms based on minitablets are often the same as those used to create bigger tablet images. However, some modifications to the production procedures and testing strategies might be needed due to their unusual size. These factors are discussed.

Minitablets are often compressed tablets that are smaller in size than standard tablets. Although the word “minitablets” (sometimes known as “microtablets”) has been used to refer to tablets having a diameter between one and four millimetres, there are presently no regulatory rules that define it (mm). Numerous minitablet products are concentrated in this size range because oral dosage forms smaller than 2.5 mm can be thought of as oral granules2 and can thus benefit from the potential flexibility in dosage form administration.

Advantages

Minitablets may have advantages, but using this dosage form may provide difficulties as well. Minitablets are difficult to manage on their own due to their small size. Thus, unless delivered with the aid of a caregiver or a dosing device, minitablets may not be the suitable dosage form for patients with motor impairment or geriatric patients. When creating minitablets for substances with a relatively low toxicity threshold, caution should be used (highly potent compounds). Compared to bigger tablets, stray minitablets are more likely to be dropped and lost, which could result in unintentional dose loss or accidental ingestion by children or animals, however, these risks can be reduced with the right package presentation.

Designing a minitablets-based dosage form for high-dose medications, or substances with low potency, might be challenging since it can require an unreasonably high number of minitablets each dose. To supply a single dose, many minitablets must be bundled together from a manufacturing standpoint, which reduces the dose-based production rate. Minitablets, therefore, seem to be best used for high-value, low-volume goods, particularly for particular patient populations that would profit from their distinctive qualities.

Situation Handling

Typically, a rotating tablet press is used to compress materials to create minitablets. 22 There are two main applications for multi-tip tooling. First of all, it boosts output and cuts down on powder dwell time in the feed frame, which can cause over-lubrication or powder segregation. Second, adding additional tips multiplies the force imparted to a single pair of opposing punch tips, resulting in a greater overall compression force that is more precisely controllable.

Both multi-part assemblies and monoblocks of multiple-tip punches are offered by vendors of tableting tools. In comparison to assembled multi-part tooling, monoblock punches are quicker to install tooling, cleaner, and more resistant to tip breakage. They can also be manufactured to tighter tolerances. Multiple-part punches, however, enable the repair of damaged punch components. In comparison to bigger tablet equipment, multi-tip tooling generally needs to meet stricter machining and mechanical stability criteria, which drives up manufacturing costs.

Round Minitablets

Round minitablets with diameters of 2, 3, and 4 mm have approximate compression weights of 7, 20, and 40 mg, respectively. Minitablets with height-to-width ratios that are almost one will be easier to package and dispense. Since deeper cups produce more spherical minitablets, they may be more advantageous for packaging. In contrast to typical or shallow concave designs, minitablets compressed using deeply concaved tooling may exhibit greater tablet density gradients. Tablet attrition can result from such gradients during the coating, packing, or other handling processes. Utilizing tapered die designs can help reduce residual strains, which will lead to fewer or smaller microdefects and more durable minitablets.

Because it affects content consistency and dosing precision, minitablet weight homogeneity is essential. Since tiny absolute weight differences will result in more substantial relative variations in potency, the tolerance for weight variability in minitablets is lower than for larger tablets. The flow of the powder is one of the most significant elements that affects the variability of tablet weight. To determine the effect of differences in powder flow qualities on the weight uniformity of 2- and 3-mm minitablets, a systematic investigation was conducted. In this investigation, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate were used to create placebo formulations.

Final Thoughts

Minitablets were then compressed directly using a tablet press with a two-paddle feeder mechanism and seven-tip round, standard concave 2- and 3-mm punches. In a full-factorial two-factor, two-level DOE technique with a single centre point, the feeder paddle speed was varied between 10 and 30 RPM and the tablet press speed was varied between 5 and 25 RPM (replicated). Utilizing the proper top-loading analytical balances, the weights of the manufactured minitablets were evaluated, and the data gathered was examined.

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