In the pharmaceutical world, dissolution is a deep quality control test. It is defined as the amount of solute or solid drug that is placed in a solution per unit of time under standardized conditions of temperature, solvent composition, and liquid or solid interface. In the dissolution testing process, solubility is the most important parameter to consider in order to achieve the desired effect. It is a challenge for most scientists to develop most drugs due to their low aqueous solubility.
A drug needs to be in a solution state to be absorbed at the site of absorption. Therefore, scientists have devised different methods to increase drug solubility, ranging from modification of drug particle size and crystal formation to the use of surfactants. The final pharmaceutical product is a solution composed of purified water, co-solvents, surfactants, preservatives, sweeteners such as glucose and saccharin, viscosity modifiers, antioxidants, colorants, flavors, and buffers to regulate pH levels. Therefore, it is essential to make sure you have the right equipment on hand.
The entire process requires a variety of apparatus to ensure a high-quality product. The following is a summary list of apparatus used in dissolution tests according to the United States Pharmacopeia guidelines:
a) Rotating Basket: It has a retention capacity of about 500 to 4000 ml. It has 50 to 200 rpm and is used in dissolving immediate-release, delayed-release chewable tablets, and delayed-release suppositories, extended-release tablets, and floating dosage forms.
b) The Palette: It has a turning speed of 25 to 50 rpm and a capacity of 500 to 4000 ml. It is used in the dissolution of immediate-release tablets, orally disintegrating tablets, chewable tablets, delayed- and prolonged-release tablets and capsules, as well as suspensions.
c) The Reciprocating Cylinder: It has a rotation speed of 6 to 35 rpm and a capacity of 250 ml. It is used for controlled release formulations, chewable tablets and pearls.
d) The Flow Cell: It has a volume capacity of up to 3 liters per hour. It is used for drugs with low solubility APIs, for powders and granules, and also for microparticles and implants.
e) The Paddle over Disk: It has a rotation speed of 25 to 50 rpm. It has a volume capacity of 500 to 4000 ml and is used for transdermal patches, ointments, floaters and emulsions.
f) The Rotating Cylinder: It has a turning speed of 25 to 50 rpm. It has a volume capacity of 500 to 4000 ml and is used for transdermal patches.
g) The Reciprocating Holder: It has a rotation speed of 30 rpm and its medium volume capacity is variable. It is used for controlled release formulations, for pH profiling and for small volumes.
conclusion
The need for dissolution apparatus in the pharmaceutical business cannot be stressed enough. Oral drug ingestion is the most convenient means of drug administration due to its high compliance among users, its cost-effectiveness, and its flexibility to accommodate the desired dose. As a result, most drug manufacturing companies are more inclined to perform dissolution testing in the production of bioequivalent oral products.
