DRUG DILIVERY SYSTEM EVALUATION PARAMETER

1. EVALUATION PARAMETER
OF PROTEIN DRUG
DELIVERY SYSTEM.
SARANSH SANJAY JAIN
(M Pharmacy)

2. CONTENT
1. Stability testing
2. Bioassay
3. UV spectroscopy
4. Bradford assay
5. Differential scanning calorimetry
6. Chromatography
7. Electrophoresis

3. Stability testing
 The capability of a particular formulation in a specific container/closure
system to remain within its physical ,chemical ,microbiological ,toxicological
and protective specification.
 It evaluate the effect of environmental factor on the quality of the drug
substance or a formulated product which is utilized for prediction or its shelf
life and proper storage condition.

4. BIOASSAY
 Due to complexity of proteins, bioassay are required to assess potency of the
formulation.
 Bioassay are of two types: In vitro and In vivo
 In case of in vitro bioassay response of cells to hormones and growth factor is
monitored. In case of in vivo bioassay pharmacological response of animal to
protein is monitored.

5. UV Spectroscopy
 Protein containing aromatic amino acid residue such as phenyl alanine, tyrosine can be detected
by UV spectroscopy. It can be used as an analytical determination methods.

6. Bradford Assay
 In the presence of protein in an acidic medium, absorption maximum of
Coomassie blue G-250 dye changes. Lastly the determination of concentration
of the protein in the sample.
 If there is no protein to bind, the solution remains brown.
 The intensity of the colored solution can be measured using a
spectrophotometer to determine the concentration of the protein in the
sample.

7. Differential Scanning Calorimetry
 DSC used as a tool for investigating of conformation as a function of
temperature and more important, the effect of potential stabilizing
excipients in a protein solution.

8. Chromatography
 Used to study stability of protein and peptide. Various modes used are:
1. Normal phase HPLC
2. Reverse phase HPLC
3. Ion exchange
4. Chromatofocusing.

9. Electrophoresis
 Sodium dodecyl sulphate (SDS) is used.
 Proteins are denatured by boiling in the SDS solution.
 All charges of protein are masked by negative charge of dodecyl sulphate.
 This technique is useful for determining molecular weight of proteins.

10. REFERENCES:-
1. Mrs. Ashwini.Joshi,
Dr.K.Jesindra Beyatricks.
Text book od Drug Delivery Systems
Prafull P Patil
Bushan P Gaykwad
Dr MG Rageeb Md Usman
Dr Suraj Sarode
Text book of Drug Deliver System(Pee Vee Publication.