Your team has discovered an effective drug, tested it, and finally, manufactured it. Mission accomplished. Not so fast — will your API make it to the target site? What if the consumer takes a dosage, but it fails to dissolve? What if it’s rendered inactive by bile salts? If you aren’t 100% certain about your product’s dosage design, it’s figuratively and literally hard work down the drain!
A lot goes into designing the best delivery system for a medication. Some of the factors that need to be taken into consideration are stomach environment, medication formulation, and product absorbability.
TABLETS
Tablets have the advantage of being economical and allowing for a wide variety of colors, shapes, sizes, and coatings. However to be a good tablet-candidate a medication needs to be homogenous. It must have equally sized and weighted particles that do not get separated out before being pressed. Otherwise, the product will be inconsistent and a nightmare for quality control.
Tablet designs are also suitable for medications that require a quick release. Sometimes the binders used to help make the tablets stick can also aid in release.
Tablet forms also allow for cutting, making medication weaning convenient or allowing for flexible dosing.
CAPSULES
For drugs that need a more controlled release, capsules might be a better choice. Some capsules are even made to pass through the entire digestive system without disintegrating, such as the shell used for Concerta.
There are two varieties of capsules: hard shell and soft shell. Soft-shell capsules are the small amber-colored pills used with vitamins D or E They are made out of a single piece of gelatin, and sealed with a single drop after being filled.
Soft capsules are useful for delivering fat to aid in the absorption of fat-soluble compounds.
Hard capsules are the kind you see with antibiotics. They are comprised of two pieces of hard gelatin, with the smaller of the two fitting inside the larger. This design dates all the way back to 1847 when it was patented by the inventor.
One disadvantage capsules have over tablets is that they can be more expensive.
However, interestingly, one advantage capsules have is that consumers perceive them as being better than tablets because of the shell. Consumers feel that the shell dissolves more quickly than a tablet.
MICRO-ENCAPSULATION
Of course, some drugs have issues that aren’t easily resolved via simple tableting or encapsulation methods. APIs that are hydrophobic or poorly absorbable may need to be micro-encapsulated to aid in delivery. Micro-encapsulation can also protect against enzyme degradation, and provide a higher degree of release-control.
There is a lot more that goes into dosage delivery besides what we've touched on here. Check out our classes here at CfPIE to learn about the best dosage systems for your team’s API .
CLASSES
Formulation Design and Troubleshooting of Dry Dosage Forms
Granulation, Tableting and Capsule Technology
The Drug Development Process from Concept to Market
Stay Informed
Since 2001 CfPIE has
Need help finding the right life sciences training courses? We can help you make the right choice based on your company's needs.
All Rights Reserved | CfPIE Inc. | Our courses and materials are copyrighted by CfPIE, Inc. and may not be used or reproduced without the written permission of CfPIE, Inc. management. | In partnership with CCC