Mannitol in wet granulation
Wet granulation is commonly used in the pharmaceutical industry to manufacture oral solid dosage forms. Owing to many favorable attributes, mannitol is finding increasing use as a pharmaceutical binder in these formulations. Standard crystallized mannitol in β-polymorphic form, while excellent for fluidized-bed granulation and wet granulation in organic solvents, often lacks sufficient binding and tableting properties for use with high/low-shear wet granulation processes. In contrast, Parteck® Delta M, the only commercially available mannitol excipient in δ-polymorph crystals, offers the inertness of mannitol with excellent binding properties, enabling formulators to more easily develop challenging formulations via wet granulation….
Excipients Play a Crucial Role
The success of a wet granulation process depends on the selection of the optimum excipients and process parameters that will provide excellent binding and compaction properties and flow. Among the most widely used fillers and binders in oral dosage forms are lactose, cellulose derivatives, and calcium phosphates. Excipients such as disintegrants and lubricants are added after wet granulation is complete.
Growing Interest in Mannitol
Interest in the use of mannitol as a filler/binder is increasing due to its physicochemical properties, such as its lower hygroscopicity (when compared with other commonly used filler/binder excipients, chemical inertness, and advantageous tableting behavior, including compactability and the ability for specific DC-grades of this material to form extremely robust tablets.
Mannitol also imparts good taste (slightly sweet) and mouthfeel, enabling its use for chewable, sublingual, and orodispersible tablet formulations. In addition, unlike lactose, a traditional standard excipient often used as a filler, mannitol is not a reducing sugar. There are also no known human tolerance issues with mannitol, as there are for lactose.
Due to these many favorable attributes, mannitol is finding increasing use as a pharmaceutical binder and thus becoming a standard excipient in formulations intended for wet granulation (as well as other processing routes). Continue reading The Application of Mannitol In Wet Granulation
pharma’s almanac – October 6, 2020PAO-10-20-CL-01 – by Hans-Leonhard Ohrem