Various methods are there for the evaluation of protein and peptide drug delivery.

1. Evaluation of Protein And Peptide Drug
Delivery System
PRESENTED BY:
MEGHA
ASSISTANT PROFESSOR

3. Evaluation
pH of Formulation
Drug Excipient
Interaction studies
Particle size
Dissolution
Encapsulation
Efficiency
%Moisture Content
Residence Time
Weight uniformity
FT-IR Spectra In vitro

4. 1.)Weight uniformity :-
For evaluation of weight, three Dosage form of every formulation are taken and
weighted individually on a digital balance. The average weights are calculated.
2.) %Moisture Content :-
%MC
Weigh the Formulation
Put in desiccator containing
fused cacl2 for 24 hrs.
Re-Weigh the formulation
Calculate % moisture
content by using formula
= Initial weigh – final weigh X 100
final weigh

5. 3.)Drug entrapment efficiency:-
 Accurately weighed 50 mg of drug-loaded microspheres were suspended in 100
ml of simulated intestinal fluid of pH 7.4 PB. The resulting solution was kept for
24 hrs. Next day it was stirred for 5 min and filtered. After suitable dilution, protein
and peptide content in the filtrate was analyzed spectrophotometrically at 259
nm using a UV-Vis spectrophotometer.
 The drug entrapment efficiency was determined using following formula:-
% DEE=Actual drug content / Theoretical drug content×100
4.)FT-IR spectra :-
 Fourier Transform Infrared Analysis (FT-IR) measurements of protein, carrier and
Protein-loaded microspheres formulations were obtained using a Perkin-Elmer
system 200 FT-IR spectrophotometer. The pellets were prepared on KBr-press
under hydraulic pressure of 150 kg/cm2 ; the spectra were scanned over the
wave number range of 4000 to 400 cm-1 at the ambient temperature

6. 5.) pH of Formulation:-
Determination of pH
Take dosage form from every formulation
pH should be recorded with the help of pH meter or pH paper
formulation are placed on agar plate for 1-2 hrs.
The mean value should be taken for each dosage.

7. 6.) Protein and Excipient Interaction studies:-
 To assess possible protein-drug excipient interaction studies Differential
scanning calorimeter (DSC), X Ray diffraction (XRD), Fourier transform intra-red
spectrum (FTIR) and Thin layer Chromatography can be used.
7.) Particle Size :-
 Determination of particle size with SEM , Electron microscopy , Transmission
Electron Microscopy , Atomic Force Microscopy.

8. 8.)In vitro Residence time :-
The test was performed in phosphate buffer of pH 7.4.
A piece of intestinal mucous (2 × 2 cm) was mounted on to glass
slides of (3 × 1 inch) with Cyanoacrylate glue.
Two glass slides were connected with a suitable support
About 50 microspheres were spread on to each wet tissue specimen
and there after the support was hung on to the arm of a USP tablet
disintegrating test machine
The disintegration machine containing tissue specimen was adjusted
at slow, regular up and down moment in a test fluid at 37°C taken in
a beaker
At the end of 30 min,., the machine was stopped and the number of
microspheres still adhering on to the tissue was counted.

9. 9.) Dissolution studies :-
 Dissolution studies are carried out for all the formulations, employing USP
dissolution apparatus at 37°C, rotated at constant speed of 50 rpm using
900ml of dissolution medium.
 The layer membrane of formulation attached to the glass disk with instant
adhesive (cyanoacrylate adhesive).
 The disk was allocated to the bottom of the dissolution vessel.
 An aliquot of the sample is withdrawn at suitable time interval and the
volume is replaced with fresh dissolution medium. The sample is
analyzed spectrophotometrically at specified nm .

10. Thank You