PROJECT DESCRIPTION

BACKGROUND

Impregnation

of

drugs

into

a

porous

carrier

can

improve

some

crucial

properties

of

the

drugs

such

as

its

dissolution

behavior,

content

uniformity,

and

flow

properties.

Therefore,

several

techniques

have

been

developed

for

loading

crystalline

drugs

into

porous

carriers.

However,

most

of

these

methods

show

many

disadvantages

and

manufacturing

problems.

Therefore,

it

is

of

interest

to

introduce

a

pharmaceutical

manufacturing

method

that

can

overcome

the

drawbacks

of

previous

loading

methods.

Also,

it

is

important

to

study

how

this

method can facilitate the drug and product development.

PROJECT GOALS

The

main

goals

of

this

project

are

to

show

the

applicability

of

fluidized

bed

impregnation

technique

and

the

advantages

of

this

technique

over

other

loading

methods.

Also,

the

improvement

in

properties

of

the

drugs

after

impregnation

into

porous

have

been

studied

to

present

the

advantages

of

incorporating

drugs

into

porous carriers.

SUMMARY OF STUDIES

In this work, the essential steps to successfully loading drugs into porous carriers have been developed. The main procedure steps include: • Preparation of API solution. • Loading porous carrier into the fluidized bed. The mass of porous carrier should be enough to reach the top spray nozzle. • Fluidizing the porous carrier using only hot air. • Spraying only solvent until reaching the steady state. Then, spraying API solution. After achieving the required loading, switching the spray back into pure solvent. • Drying and collecting the samples for further characterization tests, which include blend uniformity, flow properties, X-ray diffraction, differential scanning calorimetry, surface area and pore volume, and dissolution behavior. Figure 1 describes the required set up steps to successfully load drugs into porous carriers. Figure 1. The experimental set up of fluidized bed impregnation method To show the generality and robustness of this technique, the effects of drug loading and solvent types have been studied by loading acetaminophen into Neusilin using water and methanol as solvents. The impregnated product present acceptable blend uniformity, excellent flow properties, and a narrow particle size distribution. Also, the results suggest that the improvement in the properties of impregnated products does not depend on the drug loading or solvent type. Moreover, to explore the generality of fluidized bed impregnation method, the effect of carrier type on the properties of impregnated has also been investigated. To achieve this goal, Indomethacin (IMN) was loaded into Neusillin (NEU), Aeroperil (AER) and Fujicalin (FUJ). The results show that IMN has successfully impregnated into NEU, AER and FUJ. The results also demonstrate that the impregnated products generally have good properties, which are important for manufacturing of solid dosage forms. Figure 2 represents the schematic diagram of loading IMN into three different carriers. Figure 2. Loading of Indomethacin into three different carriers using fluidized bed dryer