Download List of References

6.
Brief resume of the intended work:
6.1 Need for the study:

Diabetes mellitus is a chronic disorder which requires controlled release of
medicament to achieve a steady state plasma concentration for longer period of
time.

In non insulin dependent diabetes mellitus conventional therapy for systemic
effect requires the frequent parenteral administration of insulin or oral
hypoglycaemic drugs which reduces the patient compliance and also requires
high concentration to maintain therapeutic effect because of the short biological
half life.

Hydrogels have received much attention not only for controlled release but also
for the site specific delivery of drugs. pH sensitive hydrogels protects the drug
that are susceptible to enzyme degradation in upper gastrointestinal tract or
acidity of stomach and releases the entire drug in the colon. Hydrogel based
drug delivery system increases the biological half life of the oral hypoglycaemic
drugs. Over the past few decades advances in hydrogel technologies have
spurred development in many biomedical applications including controlled drug
delivery.
6.2 Review of the literature:
•Gupta NV, Satish CS and Shivkumar HG, have prepared gelatin-poly(methacrylic
acid) interpenetrating polymeric network hydrogels as a pH sensitive delivery
system for Glipizide and have shown sustained release over a period of 12hour.The
release of drug was found to depend on pH, crosslinking agent concentration and
methacrylic acid content in the semi-IPN.1
• Satish CS and Shivakumar HG, have prepared and evaluated swelling and in vitro
release of insulin from semi interpenetrating polymer networks of poly(vinyl
alcohol) and poly (methacrylic acid). The swelling studies showed that the hydrogels
swelled in pH 7.4 more compared to pH 2.0 The release of insulin was maximum in
pH 7.4 and less than 5% release was seen in acidic pH.2

George M and Abraham TE, designed a pH sensitive alginate guar gum hydrogels
crosslinked with glutaraldehyde for the controlled delivery of protein drugs and
found that freeze dried alginate guar gum hydrogels can be considered as a potent
candidate for a protein delivery matrix to the intestine via the oral route.3
• Narayani, RK. Rao PK, studied the collagen-poly(HEMA) hydrogels for the
controlled delivery of methotrexate and cisplatin and found that release of
anticancer drug is possible to modulate by applying different types of crosslinking
methods.4
• Nam K, Watanabe J, Ishihara K, developed physically cross linked hydrogels
composed of two water soluble phospholipids polymers and found the insulin drug
delivery process via oral administration can be completely controlled. 5
• Patil NS, Jonathan.S, Dordick and Rethwisch DG studied the controlled release of
proteins from poly(sucrose acrylate) hydrogels and found that highly stabilizing
nature of the sucrose is responsible for controlled release of protein.6
 Carmen Alvarez – Lorenzo et al. prepared acrylic/cyclodextrin hydrogels by
coplymerization and have shown improved release and loading capacity for
hydrophobic drugs.7
 Ravichandran P, Shantha KL and Rao PK developed pH sensitive hydrogels to
achieve localized drug delivery of 5– Fluorouracil using poly(N-vinyl pyrrolidoneacrylic acid)- polyethylene glycol and in vitro release was studied that showed the
polymer could be useful for localized delivery of drugs in the stomach.8
6.3 Main objectives of the study:
The objective of the present study is as follows:
1. To formulate hydrogels consisting of a model antidiabetic drug.
2. To evaluate the prepared hydrogels for swelling studies, in vitro degradation
studies, drug compatibility studies.
3. To characterize the hydrogels by FTIR, DSC, and XRD.
4. To study the effect of various polymer composition on the drug release
profile.
5. To study the effect of varying composition of hydrogels on swelling and
drug release properties.
6.
7
To carry out the stability studies of the selected formulations.
Materials and methods:
7.1 Source of data
The data will be obtained on experimental work,
a) Preparation of the hydrogels
b) In vitro evaluation of the hydrogels and the drug loaded hydrogels.
c) Stability studies of formulations
7.2 Method of collection of data (including sampling procedures if any)
The data will be collected from the formulation studies, in vitro evaluation,
characterization of hydrogels by FTIR, DSC, SEM, XRD and stability studies of
selected formulations.
7.3 Does the study require any investigation or interventions to be
Conducted on patients or other humans or animals?
NO
7.4 Has ethical clearance been obtained from your institution in case of
7.3?
Not Applicable
8
List of References:
1.
Gupta NV, Satish CS and Shivakumar HG. Preparation and characterization of
Gelatin-poly(methacrylic acid) Interpenetrating Polymeric Network Hydrogels as a
pH sensitive Delivery system for Glipizide; Ind J Pharm Sciences. Jan-Feb 2007.
2.
Satish CS and Shivakumar HG. Dynamic swelling and in vitro release of insulin
from semi interpenetrating polymer networks of poly(vinyl alcohol) and
poly(methacrylic acid); Ind J Pharm Sciences. Jan-Feb 2007.
3.
George M, Abraham TE. pH sensitive alginate-guar gum hydrogel for the
controlled delivery of protein drugs; Int J Pharm. 2007; 335: 123-129.
4.
Narayani, KR. Rao P. Collagen-poly(HEMA) hydrogels for the controlled delivery
of methotrexate and cisplatin; Int J Pharm. 1996; 138: 121-124.
5.
Nam K, Watanabe J, Ishihara K. The characteristics of spontaneously forming
physically cross-linked hydrogels composed of two water-soluble phospholipid
polymers for oral drug delivery carrier I: hydrogel dissolution and insulin release
under neutral pH condition; Eur J Pharm. 2004; 23: 261-270.
6.
Patil
NS,
Dordick
JS
and
Rethwisch
DG.
Macroporous
poly(sucrose
acrylate)hydrogel for controlled release of macromolecules; Biomaterials.1996; 17:
2343-2350.
7.
Alvarez-Lorenzo et al. Acrylic/cyclodextrin hydrogels with enhanced drug loading
and sustained release capability; Int J Pharm 2006; 312: 66-74.
8.
Ravichandran P, Shantha KL: and Rao PK. Preparation, swelling characteristics
and evaluation of hydrogels for stomach specific drug delivery; Int J Pharm 1997;
154: 89-94.