Formulation, Development and Release Enhancement of Sustained Release Tablet of Antidiabetic Drug Glipizide by the use of Natural Polymers

 

Sonia Chauhan*, Rupa Mazumder, Rakhi Mishra, Avijit Mazumder, Nidhi Srivastava

Noida Institute of Engineering and Technology (Pharmacy Institute),

Greater Noida - 201306, Uttar Pradesh, India.

*Corresponding Author E-mail: soniya.chauhan012@gmail.com, rupa_mazumder@rediffmail.com, rakhi.misra84@rediffmail.com, avijitmazum@yahoo.com, nidhi10feb@gmail.com

 

ABSTRACT:

Background: Modification in sustained release system is a newly developed area that has shown good control over the administration of drug by maintaining systemic concentrations. Objective: The study was conducted to formulate a sustained release tablet of antidiabetic drug, glipizide, with improvement in patient’s compliance. Methods: Sustained release tablet of glipizide was prepared by using different concentration of natural polymers like guar gum, chitosan and xanthan gum as a release modifier by wet granulation method. The tablets had been analyzed by chemical and physical parameters. Drug and polymer interactions had been studied by FT-IR and in vitro drug release had been studied using rotating paddle dissolution apparatus. The release rate had been studied on different models in order to measure their release kinetics. Results: Obtained FT-IR spectra interpreted no interaction of used natural polymers. Over a period of 12 hrs the maximum drug release was 98.66%. Conclusion: The results of the study successfully revealed that the formulated sustained release tablet of glipizide could be formulated by use of natural polymers which could provide maximum drug release and this study could further be explored to formulate other doasage forms by using natural source polymers.

 

KEYWORDS: Glipizide, antidiabetic, sustained release, natural polymer, wet granulation, drug release, guar gum, chitosan, xanthan gum.

 

 


1. INTRODUCTION:

In novel drug delivery system as well as in conventional system, oral drug delivery system is most widely used method. In the modern era, conventional dosage form is suppressed by the use of sustained release tablets1, because it provides uniform release of drug over a long period of time2. It has many advantages like increased the patient convenience and compliance, enhancement of bioavailability of some drugs and reduction in cost and toxicity also3. Compared to other route of administration, oral route provides flexibility due to targeting of gastrointestinal physiology4.

 

Oral route formulations like sustained release dosage forms, maintain the concentration of drug at constant level5, also reduce the frequency of doses and can supply drug to the target site directly minimizing the unfavorable side effects6. All drugs with shorter half lives can be given through sustained release drug delivery systems7,8

 

In recent era, Diabetes mellitus is a chronic metabolic disorder affecting a large number of population, in which high blood glucose concentrations (hyperglycemia) occur and this is due to deficiency of insulin9. Glipizide is practically insoluble in water and acidic solutions. For diabetes, glipizide is a drug which is extensively used for increasing the release of insulin and to cure diabetes, but glipizide sidewise imparts a large number of adverse effects, such as nausea, vomiting, heartburn, anorexia and increased appetite after oral therapy in normal doses. It comes in the second generation sulphonyl ureas class, mainly used for treatment of type II diabetes Mellitus10,11.

It is an oral hypoglycemic agent in the second generation sulfonylurea class, used to control blood sugar concentration in type-II diabetes mellitus patients12. It stimulates secretion of insulin from the β cells of pancreatic islets tissue and may increase the number of insulin receptors. Glipizide is well absorbed after oral administration, 98-99% bound to serum proteins, about 80% of metabolites of glipizide is excreted by urine and 10% is excreted by feces13,14.

 

Nowadays, in various types of formulations of different dosage forms, use of natural polymers is in review, as the natural polymers are having very less side effects and are favorable according to patient adherence15. Use of polymers in the formulations control drug release and thus, selection of polymers is a very important aspect in designing of formulations16. Natural polymers are biocompatible and thus, they have no or very less side effects17. So, they are biocompatible and without any side effects18. This research discusses various natural polymers, their advantages over synthetic polymers and role of natural polymers in designing novel drug delivery systems19. The biological properties of natural polymers, like recognition of cell, mode of enzyme interaction and their flexibility in chemical nature20 make them polymers of choice for many formulations or in various types of dosage forms21. In oral drug delivery systems, natural polymers can be used to control the rate of reaction, for masking of unacceptable tastes, and also to provide protective and stabilizing properties22,23.

 

This research work focusses on the formulation of sustained release dosage form of glipizide, which has been prepared by the use of three types of polymers, i.e., guar gum, chitosan and xanthan24. The developed tablets have been evaluated physicochemically and also by use of FTIR, to note down the interactions of drug (glipizide) and used natural polymers25. Drug release has also been evaluated with different time intervals.

 

2. MATERIALS AND METHODS:

Following materials and methods were used for development of formulation as well as to study release enhancement of antidiabetic drug glipizide:

 

2.1. Materials:

Glipizide (source: RK Enterprises, Meerut) was used as the drug under study; xanthan gum, guar gum and chitosan (CDH Lab, New Delhi) were selected as polymers; magnesium stearate (CDH Lab, New Delhi) was used as a glidant; microcrystalline cellulose (CDH Lab, New Delhi) was selected as filler; polyvinylpyrrolidone (PVP K30, CDH Lab, New Delhi) was used as a binder and talc (CDH Lab, New Delhi) was used as lubricant. All ingredients used in the present study, were of analytical grade.

 

2.2. Preparation of sustained release tablets of glipizide:

Wet granulation method was used for preparation of all formulations, using different ratios of each polymer with the drug (drug:polymer, 1:3, 1:4 and 1:5)26. Accurate quantities of all ingredients, termed as medicament, were weighed. At first, the MCC, polymers and the drug were passed through sieve no.40. The required quantities of the medicament were mixed thoroughly in a mortar, followed by the addition of the polymer solution [prepared by dissolving the PVP30 (5%) in water] to prepare granules. The dried granules were then passed through the mesh sieve no 20 to break the aggregates. Then talc and magnesium stearate were added27 and the tablet granules were compressed into tablets by use of tablet-punching machine with 8 mm standard concave punch, as shown in Table 1.

 

2.3. Micromeritic properties:

The Micromeritic properties of the prepared granules were as follows:

 

2.3.1. Angle of Repose:

The funnel and cone method was employed in which the funnel was fixed. With angle of Repose was determined by the following equation with the use of r as the radius of base of the conical pile28:

 

θ = tan-1 h/r

 

2.3.2. Hausner’s ratio

Hausner’s ratio, was related to interparticulate friction and defines as the ratio of tapped density to bulk density29.


Table 1: Formulation of 150 mg Sustained Release Tablets of Glipizide

Ingredients

Amount (mg) Used In

F1

F2

F3

F4

F5

F6

F7

F8

F9

Glipizide

10

10

10

10

10

10

10

10

10

Guar gum

33

45

57

-

-

-

-

-

-

Xantham gum

-

-

-

33

45

57

-

-

-

Chitosan

-

-

-

-

-

-

33

45

57

Polyvinylpyrrolidone

7

12

16

7

12

16

7

12

16

Microcrystalline cellulose

97

80

64

97

80

64

97

80

64

Talc

2

2

2

2

2

2

2

2

2

Magnesium stearate

1

1

1

1

1

1

1

1

1

 


Hausner’s ratio = Tapped density - Bulk density/ Tapped density

 

2.3.3. Carr’s index

Compressibility index parameter can be obtained by measuring bulk and tapped densities. A material having values of less than 20% has good flow property. The compressibility index was determined by Carr’s Compressibility index30.

 

Carr’s index % = Tapped density – Bulk density/ Tapped density × 100

 

2.4. Evaluation of glipizide sustained release tablets:

The prepared sustained release tablets of glipizide were evaluated on hardness, friability, drug content uniformity, thickness, weight variation, and in vitro drug release with different media also31,32.

 

2.4.1. Weight variation test:

The weigh variation test was performed by the comparison of individual tablet weigh with the average weight of used 20 tablets..

 

2.4.2. Hardness:

The hardness of the tablets was calculated to predict breakage under storage conditions Monsanto hardness tester was used to check the hardness of each batch of tablet33.

 

2.4.3. Friability:

Friability of the tablets can be estimated by Roche friabilator which rotates at a rate of 25 rpm. In the friabilator, the tablets were exposed to rolling, resulting from free fall of tablets within the chamber of the friabilator. After 100 rotations (4 minutes), the tablets were again weighed and the permitted friability limit being 1.0%.

 

Friability % = Initial weight – Final weight /Initial weight × 100

 

2.4.4. Thickness:

Vernier Callipers was used for calculation of thickness of the prepared tablets. It was determined by checking the thickness of ten tablets from each formulation batch34-36.

 

2.4.5. Drug content uniformity:

Drug content uniformity was calculated by taking 5 tablets from each batch. The absorbance was measured using UV-visible spectrophotometer at 275nm, after suitable dilution.

 

2.5. In Vitro drug release characteristics:

Dissolution tests were performed in a USP dissolution test apparatus II (paddle method) at 37±0.5°C37-39. Aliquots of 5 ml were withdrawn at predetermined time intervals and were analyzed spectrophotometrically at 275 nm.

 

3. RESULTS AND DISCUSSION:

Given below, are the values depicting the results of the evaluation studies.

 

3.1. Micromeritic properties

The results of flow properties of the granules prepared for compression of the tablets, have been shown in Table 2.

 

Angle of repose was in the range of 26.48±1.670 to 31.62±1.350, indicating excellent flow of the granules for all the formulations. The Carr’s index was found to be in the range of 10.84±0.75 to 15.38±0.34, indicating good compressibility of the tablets. These values indicated that the prepared granules exhibited good flow properties.

 

Table 2: Results of Physical Evaluation of Pre-compression Blend Using Angle of Repose, Carr`s Index and Hauser’s Ratio

Formulation

Angle of Repose (ⱺ)

Carr`s Index (%)

Hauser’s Ratio

F-1

31.78

12.28

1.14

F-2

29.75

13.45

1.13

F-3

28.45

14.83

1.12

F-4

30.6

13.68

1.15

F-5

39.67

14.71

14.71

F-6

39.3

15.04

1.13

F-7

35.8

13.68

1.15

F-8

35.67

12.29

1.14

F-9

35.56

14.68

1.17

 

3.2. Evaluation of sustained release tablets of glipizide

Hardness of the tablets was found to be in the range of 5.7Kg/cm2 to 6.5 to kg/cm2. Thickness of the tablets was found to be 4.20±0.23 to 4.63±0.86mm. The friability of the tablets was found to be less than 1% and it was within the range of standard specification. The drug content for all the batches was found to be in the range of 97.62±0.25 to 99.67±0.14. The results are depicted in Table 3.

 

3.3. In Vitro Drug Release Characteristics:

As per the results of the dissolution study, formulations F-1, F-2, F-3, F-4, F-5, F-6, F-7, F-8 and F-9 showed 94.32, 95.31, 95.02, 66.96, 69.03, 68.04, 94.90, 95.31 and 98.66% of drug release, respectively. The drug released from the tablets was sustained for 8 to 12 hrs. Formulation F-9 was found to be most promising formulation as the tablets of F-9 showed sustained drug release of 97.66%, upto 12 hrs), formulation F-9 was selected as the optimized formulation, as shown in Table 4.


 

Table 3: Results of sustained release tablet formulations

Formulation

Wt. variation (mg)

Hardness (Kg/cm2)

Friability (%)

Thickness (mm)± SD

Drug content (%)

F-1

150.87±0.27

5.7±0.34

0.57±0.23

4.20±0.23

98.45±0.67

F-2

150.83±3.9

5.9±0.39

0.60±0.34

4.32±0.43

99.65±0.94

F-3

150.62±1.43

6.1±1.23

0.56±0.39

4.24±0.65

99.67±0.56

F-4

150.82±.034

5.8±1.55

0.73±0.45

4.54±0.76

97.20±0.89

F-5

150.98±1.13

6.2±0.54

0.66±0.49

4.36±0.87

97.30±0.98

F-6

150.83±0.69

6.5±1.45

0.76±0.56

4.54±0.865

98.68±0.76

F-7

150.68±1.14

5.9±2.43

0.64±0.49

4.46±0.86

98.34±1.24

F-8

150.78±2.14

6.2±1.45

0.58±0.63

4.55±0.48

98.89±0.16

F-9

150.78±1.45

6.5±2.49

0.59±0.67

4.63±0.86

99.70±1.12

 

Table 4: In Vitro Drug Release Profile of Glipizide Sustained Release Tablets

Time (hrs)

F-1

F-2

F-3

F-4

F-5

F-6

F-7

F-8

F-9

1

3.96±0.98

6.03±2.97

6.65±1.2

3.96±0.89

2.97±1.54

4.32±0.94

3.96±2.85

4.32±1.93

5.04±2.12

2

8.01±0.87

9.99±2.54

9.63±1.39

7.7±1.64

8.4±1.85

8.4±2.85

8.01±1.69

9.99±2.59

8.4±1.94

3

10.71±0.99

14.04±0.97

15.3±1.97

10.75±1.57

13.32±1.21

14.1±2.73

16.02±1.69

16.02±1.59

14.04±2.54

4

15.3±1.56

23.67±1.23

21.69±210

15.3±3.69

15.5±2.54

18.0±1.59

24.3±2.76

24.3±1.89

17.64±2.39

5

24.3±1.59

33.3±0.88

30.33±2.56

18.0±2.65

21.96±3.76

24.3±2.34

33.1±2.7

30.2±1.45

25.02±2.

6

38.59±1.76

41.04±1.87

45.9±3.56

23.3±2.67

30.2±3.85

33.33±0.75

46.2±2.85

42.03±1.45

30.33±1.45

7

49.9±1.98

47.97±0.65

59.04±2.59

27.36±2.29

37.35±2.96

37.35±1.78

53.37±1.95

47.7±2.95

35.37±.29

8

65.68±2.54

67.7±2.82

74.9±2.23

35.37±2.23

45.6±2.59

42.03±3.12

59.04±0.69

56.9±1.45

45.9±1.78

9

76.29±2.67

69.6±1.86

83.34±1.38

47.5±1.23

49.7±1.29

52.01±2.85

68.67±1.74

63.37±1.85

53.2±1.49

10

85.32±1.57

79.29±0.92

88.65±2.79

58.32±1.84

56.7±2.58

57.33±2.67

78.3±2.38

74.4±2.46

63.36±2.45

11

90.10±1.94

86.67±0.85

93.96±2.91

61.40±2.12

61.65±2.52

61.40±2.36

86.79±2.85

83.34±2.58

80.37±2.47

12

94.32±0.95

95.31±2.34

95.02±2.65

66.96±2.95

69.03±3.21

68.04±2.6

94.90±1.35

95.31±2.57

98.66±2.57

 


Fig. 1 shows the drug release from the top three formulations.

 

Fig. 1: Dissolution Profile of Glipizide from Formulations F3, F5 and F9

 

3.4 FT-IR spectroscopy:

The FT-IR of pure drug, natural polymers and the mixture of drug and polymers were recorded. The observed peak value of each was evaluated with the standard peak values of drug and polymer. No major interaction was observed. All these confirmed suitability of all excipients to the drug to formulate the sustained release tablets as shown in Fig. 2-5.

 

Fig. 2: FTIR Spectrum of Glipizide

 

Fig. 3: FTIR Spectrum of Glipizide + Xanthum Gum

 

Fig. 4: FTIR Spectrum of Glipizide + Guar Gum

 

Fig. 5: FTIR Spectrum of Glipizide + Chitosan

 

4. CONCLUSION:

By combination of different concentrations of natural polymers and using wet granulation technique, sustained release tablets were successfully produced. The formulations were subjected to graphical analysis to know the kinetic order and mechanism of drug released from the formulations and it was observed by the study that the drug was released following the zero order kinetics. It can further be concluded from the study that glipizide:Chitosan ratio of 1:6 was the most suitable combination for preparation of sustained release tablets of glipizide.

 

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Received on 19.01.2021            Modified on 16.06.2021

Accepted on 26.08.2021           © RJPT All right reserved

Research J. Pharm.and Tech 2022; 15(4):1588-1593.

DOI: 10.52711/0974-360X.2022.00265