Manufacturing of solid dose medication requires a meticulous process that should be understood well to avoid unpleasant results in patients. Because of this, proper training in solid dose operations is required for people who wish to join the industry of OSD manufacturing.
How Are OSDs Made?
The process of solid-dosage manufacturing entails knowledge and skill in utilizing technologies to bring active pharmaceutical ingredients to finished oral dose form. Be it tablets, capsules, or granules, the systematic sequence of tasks required can be learned from short courses available online that discuss each step in the operations.
Below are some of the basic information about the main tasks done during standard solid dose operations.
Dispensing is arguably the most critical step of any drug manufacturing process because it involves weighing and measuring the number of active ingredients and excipients to achieve the desired dose. During this stage, manufacturers conduct manual weighing using a weighing scale or use equipment to assist in lifting or transferring the ingredients such as a vacuum loading or screw feed system. However, this particular step in solid dose operations requires a trained professional to ensure that measurements are accurate.
Oral solid dose manufacturers proceed with sizing the ingredients. This involves tasks to reduce the size of the ingredients through milling, grinding, crushing, or pulverization. According to experts, this step is critical to achieving expected results because having ingredients in the same size allows uniformity of the dose.
During this step, manufacturers use machines like the fluid energy mill, ball mill, colloidal mill, hammer mill, roller mill, cutting mill, and conical mill.
This step in the manufacturing process involves mixing all substances that need to be incorporated in the drug, including the active pharmaceutical ingredient and the excipients. Diffusive mixers are considered a simple, reliable, and affordable equipment for the job. Although these machines have their setbacks, the proper use of diffusive mixers has proven to be beneficial to the manufacturing process.
Mixing ingredients for solid dose products are quite different compared to liquid-form medicines. This is because perfect homogeneity is quite difficult to achieve with OSDs due to the inherent resistance to movement and cohesiveness of each particle. Because of this, granule- and powder-based oral drugs undergo more stages of granulation and mixing which involves an ideal mixing time to avoid having a bad product. Moreover, instances, when lubricants need to be added, are a more daunting task because the timing is critical to achieving optimum results.
Manufacturing solid dose drugs require drying to avoid product deterioration caused by excessive moisture. Some of the well-known machines used in this process are the microwave dryer, vacuum tray dryer, spray dryer, turbo-tray dryer, freeze dryer, pan dryer, and bed dryer.
After the ingredients have been dispensed, sized, mixed, blended, and dried, the OSD manufacturer should now proceed with tableting or encapsulating the product. Basic tableting procedures involve compression of the mixed ingredients through stamping press using a single punch machine or a rotary press with the help of a multi-station machine.
Aside from giving tablets their shape, tablet presses can stamp the brand name or logo of the company responsible for manufacturing the medicine.
Encapsulation and Coating
Encapsulating is the process of enclosing granulated or powdered active pharmaceutical ingredients in a pod-shaped container made of gelatin substance. According to some drug manufacturers, encapsulation sometimes provides a cheaper alternative to tableting as it would allow them to save on formulation costs and API supplies.
Meanwhile, the coating is done for some kinds of OSDs for various reasons such as avoiding environmental exposure (moisture and light) and reducing the bitter taste when administered to a patient.