4.1.1. The first step in any oral solid dose manufacturing process is dispensing the raw materials. In this step, the API and excipient raw materials are weighed accurately and blended in a processing vessel. Some initial processing, such as milling, delumping, or screening, may be required to achieve homogeneous blending of the raw materials and proper particle size. Dust is often the major safety concern, and some materials require special isolator technologies.[32][33]
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4.2.1. Dry granulation is the process of compacting powders to larger particulates by applying mechanical stress. Compaction forces air out to create a stable compact, which is then milled to create the appropriate-sized granules.
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4.3.1. Wet granulation is the most common method of granulation and is a process of mixing the dry ingredients with a wet binder, such as water or solvent. After the API and excipients are milled, delumped, or screened, the blend of excipients and APIs are mixed with water or solvents. Depending on the equipment, especially the type of impeller used in mixing, the process can be high or low shear. Choppers or impellers are common, which generate high-shear forces. High-shear granulation excels in producing dense granules with diameters less than 2 mm.[36] If the viscosity and density of the liquids is similar, or if the solids readily dissolve, low-shear impellers can be employed. These hydrofoil impellers lack sharp edges, and the resulting flow-based mixing is more laminar and less turbulent.[37]
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4.4.1. Spray-drying is a widely used technique for converting liquid formulations into dry powders through atomization and rapid solvent evaporation in a heated gas stream. Originally developed for food and dairy applications, spray-drying has become an essential process in pharmaceutical and biopharmaceutical formulation, particularly for producing powders with controlled particle properties, enhanced stability, and improved bioavailability.[42][43]
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4.5.1. Hot-melt extrusion (HME) is a continuous manufacturing process for mixing materials using a rotating screw. Single-screw extruders (SSE), twin-screw extruders (TSEs), or multi-screw extruders (MSEs) are all employed within the pharmaceutical industry. Temperatures are maintained above the glass transition temperature (Tg) or even the melting temperature (Tm) of the materials involved. The technique has been gaining popularity since the 1970s because it enables efficient mixing of water-insoluble or poorly soluble active pharmaceutical ingredients (APIs) at low temperatures, with low shear forces, and with smaller requirements for solvents. Final dosage forms prepared with HME can also benefit from increased efficiency of drug delivery to the patient.[53]
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4.6.1. No matter the granulation method, granules with appropriate characteristics are processed into tablets. Small-scale tablet manufacturing can be done on a single punch machine, in which one tablet is compressed at a time. Commercial tablets are manufactured on rotary tablet presses, which operate continuously. Tablet presses are designed to apply precise, consistent pressure to form the pill. Such machines are efficient, capable of producing large quantities of tablets, and versatile enough to produce various shapes, sizes, and formulations. The ideal particle size for compression into tablets is 75–850 microns.[34]
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4.7.1. Hard capsules are manufactured as empty shells and subsequently filled with appropriate granule, powder, or pellets. Manufacturing of the empty hard capsules involves eight steps, which are summarized in Table 11. The final empty capsule must adhere to the same quality standards as the API itself. To ensure quality, final capsules are imaged to assess any bubbles, dark spots, or improper fit.[61] Small-scale equipment can fill 200–2,000 capsules per hour, whereas a commercial filling line can manufacture 42,000 capsules per hour.[62]
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