What is Biorelevant media?

What is Biorelevant media?

Biorelevant media simulate gut fluids more accurately than any other dissolution media. They contain components (bile salts, phospholipids and salts) which replicate conditions found in the gastrointestinal tract such as the solubilizing properties, pH and osmolality.

What is intrinsic dissolution?

The intrinsic dissolution rate is defined as the rate of dissolution of a pure pharmaceutical active ingredient when the surface area, stirring speed, pH and ionic strength of the dissolution medium is kept constant.

What is dissolution Slideshare?

DISSOLUTION Definition: • Dissolution is a process in which a solid substance solubilizes in a given solvent i.e. mass transfer from the solid surface to the liquid phase. • Dissolution is the rate determining step for hydrophobic, poorly aqueous soluble drugs.

What are the importance of Biorelevant media in formulation and development?

Biorelevant Media contain bile salts and lecithin to replicate fluids from different regions of the gut. They also represent both ‘fasted’ and ‘fed’ states. And even simulate fluids of different animal species. They can help you determine biorelevant solubility: how much drug product dissolves in the gut.

What is the pH of FeSSIF?

Fed State Simulated Intestinal Fluid (FeSSIF) Media has a pH of 5.00 and an osmolality of about 670 mOsmol/kg.

How do you do intrinsic dissolution?

To calculate the intrinsic dissolution rate, plot the cumulative amount of sample dissolved per unit area of the compact against time until 10% is dissolved. The cumulative amount dissolved per unit area is given by the cumulative amount dissolved at each timepoint divided by the surface area exposed (0.5 cm²).

What is difference between solubility and dissolution?

Dissolution is the process where a solute in gaseous, liquid, or solid phase dissolves in a solvent to form a solution. Solubility is the maximum concentration of a solute that can dissolve in a solvent at a given temperature.

How many types of dissolution media are there?

Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.

How do I prepare for FaSSIF media?

Dissolve 3.3 g of sodium taurocholate in 500 mL blank FaSSIF. Add 11.8 mL of a solution containing 100 mg /mL lecithin in methylene chloride, forming an emulsion. The methylene chloride is eliminated under vacuum at about 40°C. Draw a vacuum for fifteen minutes at 250 mbar, fol- lowed by 15 minutes at 100 mbar.

How do you prepare simulated intestinal fluid?

The simulated intestinal fluid was prepared by the similar method: potassium phosphate monobasic (10.2 g) and SDS (3.75 g) were dissolved in a same 1000 ml of deionized water and then pH adjusted to 6.8 ± 0.1 with 1 N NaOH. Finally, the volume of each fluid was adjusted to 1500 (ml) with deionized water.

What does FaSSIF stand for?

Specifically fasted state simulating intestinal fluid (FaSSIF) was developed to simulate fasting conditions in the proximal small intestine.

What is microbiological media preparation?

Microbiological Media Preparation Page 1 2/18/2015 Microbiological Media Preparation Overview Growth medium or culture medium is a gel or liquid designed to support the growth of microorganisms or cells. There are different types of media for growing different types of organisms or cells. One commonly used type of media is nutrient broth or agar.

What is Biorelevant medium in pharmacology?

Biorelevant Media. This biorelevant medium simulates the fluid found in the small intestine before a meal. The small intestine is the site of absorption for oral dosage forms. It is therefore very important to use biorelevant dissolution tests to get a more accurate idea of how much drug is likely to be absorbed in vivo.

Are biorelevant instant powders a source of microbiological contamination?

It was shown that biorelevant instant powders are not a source of microbiological contamination. It was also established that the physical characteristics of FaSSGF and FeSSIF are invariant with time, so they can be used immediately after preparation, i.e., without any equilibration time.

How to evaluate the quality and stability of biorelevant media?

Stability and Quality Tests To evaluate the quality and stability of the biorelevant media, freshly prepared media were subjected to an initial assessment and assessment during and after several days of storage at two storage temperatures (n= 3 for each time/storage condition), as shown in Figure 1.