Oral Solid Doses
An oral solid dose drug or medication comes in solid form and is administered through the mouth of the patient. While it may come in granulated or powdered form, OSDs are more commonly seen as tablets and capsules.
Tablets and capsules have become known for the convenience they provide because they can easily be administered to or consumed by the patient. Also, both forms of OSDs have been proven to be effective in dissolution, whether through the digestive tract or other means.
Tablet vs. Capsule
Thanks to pharmaceutical innovations, there are already several kinds of tablets and capsules available in the market today. In fact, some manufacturers even came up with the “caplet,” a tablet that takes the shape of a capsule. With its emergence, the debate over which of the two popular forms of OSD provide more benefits has ensued.
Tablets are deemed to have the advantage of being tamper-resistant because it comes as a solid compressed mass of medication. It is also considered to have a longer shelf-life and can maintain its optimum potency for a longer period. However, this form of OSD has one major disadvantage: it is the most difficult to swallow.
Capsules, on the other hand, have the upper hand when it comes to ease of consumption because its standard size and shape promotes better swallowing compared to the tablet. On top of that, it doesn’t have the bitter taste and pungent scent found in some tablets. It is also seen as a great way to administer drug easier because after the gelatin casing breaks down, the contents that include the API is immediately released. Unfortunately, this quality of capsules also makes it more prone to tampering and is deemed less safe compared to tablets.
The Manufacturing Process
The solid dose manufacturing process is quite similar when it comes to tablet and capsules. Listed below are the main unit processes of manufacturing so-called “batches” of granulation mixture.
It is during this unit process that manufacturers decide what to include in the active ingredients of a drug to provide better dissolution and binding, improved flow of powder, and additional flavor and color. These substances are called “excipients.” Different excipients are needed for various kinds of OSDs.
After dispensing the ingredients for the formula, it is time to granulate. The goals of this process include improving compressibility and powder flow, reducing fine powders, controlling density and segregation tendency, and fusing and capturing quantities of the active ingredient.
The next phase of the solid dose manufacturing process is milling. This process aims to improve drying, reduce segregation, and improve flow. It is also done to ensure that the distribution of wide particles is limited to the set amount, which is why milling machines are used in various unit operations.
One important thing manufacturers should remember during milling is to be very careful with “fines,” or the very small particles that appear like dust. These don’t compress well, can become airborne, and might impede flow.
Blending is the process of somewhat mixing all the ingredients together in a way that would evenly distribute wet excipients like lubricants to achieve content uniformity and potency.
Tableting, more commonly known as “tablet compression,” is the process where the final blend of ingredients is pressed together to form the tablet. It is also during this time that the label, mark, or logo of the manufacturer is stamped onto the tablet.
Often, manufacturers add a coating to the tablet to protect it from moisture, heat, and light, thereby making it stronger. The coating also adds tastes and color to the tablet with the use of a water-based solution.
This is the process where granules are put into capsules made of dissolvable gelatin. Most encapsulation machines used in big pharmaceutical companies are automated. However, some still use hand-operated equipment where an operator organizes capsules into an upright position before filling them up with the medicines.