CHAPTER 2 NEED AND OBJECTIVE

II. NEED AND OBJECTIVES

2.1 NEED OF THE STUDY:

Diabetes mellitus is the most common chronic endocrine illness, affecting over 100 million
people globally. Diabetes mellitus is a metabolic condition caused by a mix of inherited and
environmental factors, with abnormally high blood sugar levels (hypoglycemia) 114mg/dl.
Since 1921, when insulin become medically available, all forms of diabetes have been
treatable, but there is no cure. Type 1 diabetes is controlled with a mix of dietary changes,
exercise, medication, and insulin supplementation, whereas Type 2 is managed with a
combination of dietary changes, exercise, medication, and insulin supplementation.

Sitagliptin Phosphate Monohydrate is a dipeptidyl peptidase 4 (DPP4) inhibitor antidiabetic

for the treatment of Type 2 diabetics. DPP4 inhibitors are a class of compounds that work
affecting the action of natural hormones in the body called incretins. It lowers blood sugar
levels by boosting sugar intake by the body, mostly through increased insulin synthesis in
the pancreas, and reducing sugar production by the liver. Sitagliptin Phosphate Monohydrate
is a recent advancement in the treatment of Type 2 diabetes The drug is currently available
as an extended-release tablet with a dose of 25mg/50mg/100mg.

Considering the therapeutic management of diabetes there is a need to develop mouth

dissolving tablets required initially for naive patients for immediate therapeutic response.
Furthermore, the innovative formulation of Sitagliptin Phosphate Monohydrate MDT
employing Natural Disintegrant has the potential to improve patient compliance, provide the
rapid start of the action, and provide the optimum management of type 2 diabetes mellitus
when compared to standard dose forms.

“FORMULATION AND EVALUATION OF SITAGLIPTIN MOUTH DISSOLVING

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TABLET USING NATURAL DISINTEGRANT”
CHAPTER 2 NEED AND OBJECTIVE

2.2 OBJECTIVES

The objective of the present study are:

1. To formulate mouth dissolving tablet by direct compression method.

2. Evaluation of various parameters of a made sitagliptin phosphate monohydrate mouth

dissolving tablet.

3. Using 32 factorial designs, investigate the effect of formulation components on responses.

4. To extract hibiscus mucilage from the leaves of Hibiscus rosa sinesis and use it to make
mouth dissolving tablets.

5. To use Psyllium (Plantago Ovata Forsk) husk powder as a natural super disintegrant in
the formulation of MDT.

6. To look at the effect of different concentrations of natural super disintegrant in different

batches of the formulation.

“FORMULATION AND EVALUATION OF SITAGLIPTIN MOUTH DISSOLVING

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TABLET USING NATURAL DISINTEGRANT”
CHAPTER 2 NEED AND OBJECTIVE

2.3 PLAN OF WORK

➢ PHASE 1
• Problem selection.
• Problem feasibility.

➢ PHASE 2

• Literature review.

• Selection of drug, method, natural disintegrant, suitable solvent for the preparation
of mouth dissolving tablet.

• Procurement of drug and chemicals selection of excipients.

➢ PHASE 3

• Preformulation studies of drugs and excipients.

• Calibration curve by UV spectrometer.

• Preparation and collection of natural super disintegrant.

• Preliminary compatibility studies.

➢ PHASE 4

• Physical and chemical characterization of natural super disintegrants.

• Optimization of the formulation.

➢ PHASE 5

• In-vitro characterization.

• evaluation of tablets.

• Calculation and result interpretation.

• Thesis writing.

“FORMULATION AND EVALUATION OF SITAGLIPTIN MOUTH DISSOLVING

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TABLET USING NATURAL DISINTEGRANT”