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
• 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 pyrrolidone-acrylic 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:
- To formulate hydrogels consisting of a model antidiabetic drug.
- To evaluate the prepared hydrogels for swelling studies, in vitro degradation studies, drug compatibility studies.
- To characterize the hydrogels by FTIR, DSC, and XRD.
- To study the effect of various polymer composition on the drug release profile.
- To study the effect of varying composition of hydrogels on swelling and drug release properties.
- To carry out the stability studies of the selected formulations.
7 / 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:
- GuptaNV,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;IndJ Pharm Sciences. Jan-Feb 2007.
- 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);IndJ Pharm Sciences. Jan-Feb 2007.
- George M, Abraham TE.pH sensitive alginate-guar gum hydrogel for the controlled delivery of protein drugs; Int J Pharm.2007;335: 123-129.
- Narayani,KR.RaoP. Collagen-poly(HEMA) hydrogels for the controlled delivery of methotrexate and cisplatin; Int J Pharm.1996;138:121-124.
- 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.
- PatilNS, Dordick JS and Rethwisch DG.Macroporous poly(sucrose acrylate)hydrogel for controlled release of macromolecules; Biomaterials.1996;17:2343-2350.
- Alvarez-Lorenzo et al.Acrylic/cyclodextrin hydrogels with enhanced drug loading and sustained release capability; Int J Pharm 2006;312:66-74.
- 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.