INTRODUCTION:

In this study, zolmitriptan is studied and worked on it. Zolmitriptan is used to treat migraine. It gives relief from pain, headache, and other symptoms of migraine including nausea, vomiting and sensitivity to light/ sound. This drug works by helping blood vessels in brain to return to normal size. It may also block pain signaling in the brain. Zolmitriptan binds with high affinity to human recombinant 5-HT_1D,5-HT_1Breceptors also moderate affinity for 5-HT_1A receptors leading to cranial blood vessel blood vessel constriction.^{5, 19}

Tablets remain popular as a dosage form because of advantage afforded both to the manufacturer and the patient. Although the basic mechanical approach for most tablets manufacturers has remained the same; tablet technology has undergone great improvement and experimentation.³ Also, tablets have They have the best combine properties of chemical, mechanical and microbiologic stability of all the oral dosage forms. They may provide the greatest ease of swallowing with the least tendency for “hang-up” above the stomach especially when coated, provided that tablet disintegration is not excessively rapid.⁴In this study, direct compression as a method of tablet manufacture was reserved for a small group of crystalline chemical having all the physical characteristics required for the formulation of a good tablet. Approaches being used to make this method more universally applicable include the introduction of formulation additives capable of imparting the characteristics required for compression and the use of force-feeding devices to improve the flow of powder bled. For, tablets in which the drug itself constitute a major portion of the total tablet weight, it is necessary that the drug posses the physical characteristic require for the formulation to be compressed directly. These commercially available direct compression vehicles may contain small quantities of other ingredients (eg. starch) as processing yields. The disintegration and dissolution of directly compressed tablets depends on single or combined effect of disintegrant, water soluble excipients and effervescing agents. It is essential to choose a suitable and an optimum concentration of disintegrant to ensure fast disintegration and high dissolution rates. The main advantages for direct compression technique are fewer unit operations compared with wet Granulation (shorter processing time and lower energy consumption) and fewer stability issues for actives that are sensitive to heat or moisture.^{13, 14}

MATERIALS AND METHODS:

Materials:

Zolmitriptan was procured from Glenmark Pharmaceuticals, Sinnar, Nashik, Maharashtra, and Xanthan Gum from Signet Chemicals, Croscarmellose Sodium from Research-Lab Fine Chem, Mumbai, and Mannitol from Thomas Chemicals Pvt. Ltd., Mumbai, Microcrystalline Cellulose from Loba Chemicals, Mumbai, Magnesium Stearate from Pure Chem Lab, Pune, Sodium Saccharin from Research-Lab Fine Chem, Mumbai, Lactose from Research-Lab Fine Chem, Mumbai. All materials used were of pharmaceutical grade.

Methods:

The tablets were checked for their physical parameters like appearance, weight variation, hardness, disintegration time and friability. Indian Pharmacopoeia limits were followed for weight variation, friability and disintegration tests and finally comparative study was done between optimized batch F7 and marketed formulation. Also data analysis is determined

Formulation design: ^{6-9, 13}

The tablet consisted of Zolmitriptan (2.5mg), Croscarmellose Sodium, mannitol, microcrystalline cellulose, magnesium stearate, sodium saccharin and lactose. The weight of tablets in each batch was varied depend on the independent variables. Effect of dependent variables like disintegration time, wetting time and % drug release were studied and discussed. Formula for preparation of mouth dissolving tablet of zolmitriptan was given in table no. 1.

PREPARATION OF ZOLMITRIPTAN MOUTH DISSOLVING TABLETS:

Tablets containing Zolmitriptan were prepared by direct compression method. Tablets are compressed directly from powder blends of active ingredient and suitable excipients. Drug, Croscarmellose Sodium, mannitol, microcrystalline cellulose, magnesium stearate, sodium saccharin and lactose were mixed together and passed through sieve 22 #. Magnesium stearate was added and mixed for 5 min and again passed through sieve 22 #. Then powder blend was compressed into the tablets on tablet punching machine (Karnavati).

EVALUATION OF ZOLMITRIPTAN MOUTH DISSOLVING TABLET:

A) PRE COMPRESSION STUDIES: ^{16, 19}

1. Angle of repose:

Angle of repose was determined by using funnel method. Funnel was attached to the burette stand, the height of which was adjusted such that its tip just touches the apex of powder. The graph paper sheet was placed below the funnel. The powder was allowed to flow through the funnel freely onto the surface of the graph paper sheet. The angle of repose was calculated by the following formula,

tan θ = h/r

Where, θ = Angle of repose, h = weight of powder heap, r = radius of power heap

Table 1: Formulation of Zolmitriptan mouth dissolving tablet

Formulation Code	F1	F2	F3	F4	F5	F6	F7	F8	F9
Ingredients (in mg)	F1	F2	F3	F4	F5	F6	F7	F8	F9
Zolmitriptan	2.5	2.5	2.5	2.5	2.5	2.5	2.5	2.5	2.5
Xanthan Gum	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5
Croscamellose Sodium	20	20	20	40	40	40	60	60	60
Mannitol	18	18	18	18	18	18	18	18	18
Microcrystalline cellulose	20	30	40	20	30	40	20	30	40
Magnesium stearate	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5
Sodium saccharin	10	10	10	10	10	10	10	10	10
Lactose	76.5	66.5	56.5	56.5	46.5	36.5	36.5	26.5	16.5
Total (in mg)	150	150	150	150	150	150	150	150	150

2 Bulk density and Tapped density:

Bulk density was determined by measuring the volume known mass of powder sample that has been passed through a screen into a graduated cylinder. Into a 10ml cylinder, without compacting, approximately 5gm of test sample, M weighed with 0.1 % accuracy was introduced. The powder bed was leveled carefully without compacting, and the unsettled apparent volume V_b_, was read to the nearest graduated unit.

Bulk density (ρ₀) = M/ V₀

Where,

D₀ = Bulk density,

M = Mass of powder taken,

V_b= Apparent unsettled volume

Tapped density was determined by using graduated cylinder method. Tapped density was achieved by mechanically tapping a measuring cylinder containing powder sample and was allowed to drop under its own weight using suitable mechanical tapped density tester which operated for a fixed number of taps until a powder bed volume has reached a minimum. Using the weight of drug in cylinder and this minimum volume, tapped density may be calculated

Tapped density (ρ₀) = M/ V_t

Where,

ρ₀ = tapped density,

M = weight of powder,

V_t= tapped volume of powder in cm³

2. Compressibility index and Hausner’s ratio:

The Compressibility index and Hausner’s ratio are measure of propensity of a powder to be compressed. Both are one of the ways of measurement of free flowing ability of powder is compressibility.

Tapped density- Bulk density

Compressibility index =---------------------- X 100

Tapped density

Hausner’s ratio = Bulk density / Tapped density

Lower Hausner’s ratio: better flowability

Higher Hausner’s ratio: poor flowability

B) POST COMPRESSION STUDIES:^1–4

1. Hardness:

Using Monsanto tablet hardness tester, hardness or crushing strength of the tablet was checked.

2. Friability:

Using Roche friabilitor friability of the tablet was checked. Tablets were rotated at 25 rpm for 4 minutes or up to 100 revolutions. The tablets were then reweighed after removal of fines and the percentage of weight loss was calculated.

Initial weight- Final Weight

Friability =---------------------------------------- X 100

Initial weight

3. Thickness:

Three tablets were taken from each formulation and their thickness was determined by using micrometer screw gauge.

4. Uniformity of weight:

The weight of a tablet being made is routinely measured to ensure that a tablet contains proper amount of drug. Weight variation test was done with 20 tablets. It was the individual variation of tablet weight from the average weight of 20 tablets.

5. Disintegration Time:

Disintegration time for MDT was determined using USP disintegration apparatus with distilled water. The volume of medium was 900 ml and temperature was 37± 0.2°C. The time in seconds taken for complete disintegration of the tablet with no palatable mass remaining in the apparatus was measured. To comply the test all tablets should disintegrate within 3 minutes.

6. Wetting time:

Wetting time corresponds to the time taken for the tablet to disintegrate when kept motionless on the tongue. Wetting time is closely related to the inner structure of the tablets and to the hydrophilicity of the excipient. A piece of tissue paper folded double was placed in a Petri-plate (internal diameter is 10 cm) containing 10 ml of water. The tablet was placed on the paper and the time for complete wetting of the tablet was measured in seconds. The method was slightly modified by maintaining water at 37 ˚C.

7. Drug Content:

Weigh and powder 2 tablets of zolmitriptan. Weigh accurately a quantity of the powder containing about 10mg of zolmitriptan and dissolved in 100ml of ethanol, methanol and phosphate buffer pH 6.8 to produce 100µg/ml solution and measure absorbance of resulting solution at 285, 285.1, 282 nm respectively using UV spectrophotometer.

8. In-vitro drug release study:

In-vitro release rate study of mouth dissolving tablets was carried out using the Paddle apparatus method. The dissolution test was carried out using 900ml of 6.8 pH phosphate buffer at 37⁰C+0.5⁰C and 50 rpm. A sample (5ml) of the solution was withdrawn from the dissolution apparatus at 1, 2, 3, 4, 5 min and it was filtered. The withdrawn volume was replaced with fresh dissolution media and the absorption of filtered solution was checked by UV spectroscopy at 282 nm. The percent drug release was calculated.

9. Stability Study:

The optimized formulation was wrapped in aluminum foil and subjected to 40 ±0.5°C temperature in oven for the period of one month to three month. The formulation was analyzed for organoleptic characteristics, hardness, disintegration time, and drug content and drug release.

RESULT AND DISCUSSION:

The present study was to formulate mouth dissolving tablets of Zolmitriptan using Croscarmellose sodium (60 mg) as superdisintigrant, microcrystalline cellulose (20 mg) and xanthan gum as hydrophilic disintegrating excipient for Rapidly Disintegrating Tablets, as xanthan gum having is biodegradable, directly compressible and exhibited desirable swelling dynamics, also it gives mucoahesive property hence, avoids hepatic metabolism. The mouth dissolving tablets formulated with lower level of xanthan gum and higher level of croscarmellose sodium was selected as the optimized formulation that displayed nine fold reductions in lag time, was stable for a period of 12 months and retained the rapid disintegration characteristics till the end of tested time period. Prepared mouth dissolving tablets were evaluated for physicochemical properties, wetting time, disintigration time, in-vitro dissolution studies and stability studies.

Drug-Excipients Compatibility Studies: ^{3,
6, 11, 15}

Fourier Transform Infrared Spectroscopy:

FTIR of Pure Zolmitriptan shown in figure 1. Physical mixture of Zolmitriptan and formulative ingredients were subjected to ascertain whether there was any interaction between drug and excipients used. (FTIR of physical mixture of Zolmitriptan and formulative ingredients shown in figure 2) The IR spectra have showed similar characteristic peaks at their respective wavelengths with minor differences. The similarity in peaks indicated the compatibility of drug with formulation excipients. IR spectra of physical mixture of drug with formulative ingredients depicted below.

Figure 3: DSC thermogram of Zolmitriptan

Figure 4: DSC thermogram of Physical mixture

Table 2: Evaluation of Powder Blend for Flow Properties

Batches

Parameter

Angle of

Repose (°)

36.3±

1.4

36.59±

0.5

37.28±

0.4

31.13±

0.1

35.5±

0.07

33.1±

0.07

24.1±

0.07

26.73±

0.1

27.1±

0.07

Bulk Density

(g/ml)

0.629±

0.8

0.58±

0.02

0.63±

0.0 8

0.608±

0.1

0.602±

0.1

0.624±

0.1

0.97±

0.04

0.621±

0.1

0.59±

0.08

Tapped Density

(g/ml)

0.673±

0.5

0.69±

0.01

0.78±

0.04

0.6±

0.007

0.6±

0.005

0.768±

0.3

0.771±

0.3

0.77±

0.03

0.73±

0.01

Carr’s Index (%)

13.4±

0.07

13.3±

0.07

13.5±

0.07

12.3±

0.2

12.61±

0.1

13.9±

0.1

5.21±

0.1

6.51±

0.09

7.15±

0.1

Hausner’s

Ratio

1.07±

0.08

1.057±

0.1

1.19±

0.20

1.193±

0.2

1.133±

0.2

1.293±

0.2

1.01±

0.2

1.09±

0.2

1.11±

0.2

(* mean of three values ± SD)

B) POST COMPRESSION PARAMETERS:

All formulated tablets were evaluated for parameters such as shape, color, thickness, hardness, friability, weight variation, drug content, disintigration time, wetting time, in-vitro dissolution studies, comparative study, stability studies.

1. General appearance:

All the mouth dissolving tablets from each batch were found to be flat, white in color, circular in shape, and having good physical appearance. There was no change in color of tablets from all nine batches.

2. Weight variation:

All the tablets from each formulation passed weight variation test, as the % weight variation was within the pharmacopoeias limits of ±7.5% of the weight. The weight variation of Zolmitriptan mouth dissolving tablet was found to be 3.1% to 5%. (Values of weight variation were tabulated in table 3.)

3. Thickness and diameter:

Tablet thickness should be controlled within ±1% variation of standard value to facilitate packaging and consumer acceptance. The tablets showed thickness and diameter in the range of 4.1 mm to 4.9 mm, 5.1mm to 5.2 mm respectively. (Values of thickness and diameter were tabulated in table 3.)

4. Hardness:

Tablet required certain amount of strength, harness to withstand mechanical shocks during manufacture, packaging and shipping. The hardness was found to be in the range of 2.14 to 2.6 Kg/cm². The obtained result gives that the tablets were having good mechanical strength and compactness. (Values of hardness were tabulated in table 3.)

5. Friability:

Adequate tablet hardness and resistance to friability are necessary to prevent damage to the tablet during manufacture, packaging and transport. % friability of tablets less than 1% was considered acceptable. % friability ranged from 0.36% to 1.51%. (Values of friability were tabulated in table 3.)

1. Disintigration time:

Disintigration the first important step for drug absorption from a solid dosage form after oral administration was preliminary focused. The internal structure of tablets that is pore size distribution, water presentation into tablets and swelling of disintigration substance are suggested to be the mechanisms of disintigration. This indicates that the tablets would disintegrate almost instantaneously when they will come in contact with even slight amount of saliva in the mouth. Disintigration time was determined as per I.P. for all the formulations. Least disintigration time was shown by formulation containing Croscarmellose sodium (20 mg), microcrystalline cellulose (40mg) and highest disintigration time was shown by formulation containing Croscarmellose sodium (60 mg), microcrystalline cellulose (20mg). (Values of disintigration time were tabulated in table 3.)

2. Wetting time:

Wetting time is an important parameter related to water absorption ratio, which need to be assessed to give an insight to the disintigration properties of the tablets. Wetting is closely related to the inner structure of the tablets and hydrophilicity of the excipients. Wetting time was used as a parameter to correlate with disintigration time in oral cavity. This is an important criterion for understanding the capacity of ingredients to swell in presence of little amount of water. Since, the dissolution process of a tablet depends upon the wetting followed by disintigration of the tablet, the measurement of the wetting time may be used as another confirmative test for the evaluation of mouth dissolving tablets. It was found that formulation containing least amount Croscarmellose sodium (20 mg) having wetting time 2 min 56 sec whereas, formulation containing highest amount of Croscarmellose sodium (60 mg) having wetting time 31 sec. (Values of wetting time were tabulated in table 3.)

Table 3: Physical evaluation of formulations of F1 to F9

No	Parameter	F1	F2	F3	F4	F5	F6	F7	F8	F9
1	% Weight variation	4.2	4.6	4.9	4.9	5	4.9	3.1	3.9	3.9
2	Thickness (mm)	4.1±0.01	4.1±0.02	4.9±0.02	4.9±0.01	4.5±0.01	4.5±0.01	4.5±0.01	4.5±0.01	4.4±0.01
3	Diameter (mm)	5.1±0.05	5.1±0.02	5.2±0.04	5.1±0.01	5.2±0.3	5.1±0.01	5.1±0.01	5.1±0.01	5.1±0.01
4	Hardness (Kg/cm²)	2.55±0.2	2.57±0.1	2.58±0.23	2.14±0.3	2.17±0.3	2.19±0.3	2.5±0.3	2.5±0.3	2.6±0.3
5	Friability (%)	1.51±0.01	0.69±0.3	1.55±0.3	0.36±0.06	0.46±0.06	0.56±0.06	0.45±0.06	0.76±0.06	0.46±0.6
6	D.T. (min)	0.5±0.1	1.10±0.09	1.3±0.3	0.43±0.1	0.45±0.1	0.47±0.1	0.30±0.1	0.35±0.1	0.40±0.1
7	Wetting time (min)	1.4±0.03	1.44±0.3	2.56±0.1	1.1±0.2	1.15±0.5	1.20±0.5	0.31±0.3	0.49±0.3	0.53±0.3
8	Drug Content (%)	67.4±0.7	64.3±0.5	59.8±0.3	91.4±0.71	71.4±0.7	70.6±0.5	99.4±0.7	96.4±0.7	94.4±0.7
9	% CDR (at 6 min)	90.00	86.0	89.77	94.33	95.87	89.77	99.24	98.33	97.89

(D.T. = Disintigration time, * mean of three values ± SD)

Comparative study:

The final optimized formulation (F7) of Zolmitriptan containing croscarmellose sodium (60 mg), Microcrystalline cellulose (20mg) was compared with marketed conventional tablet of Zolmitriptan (Zomig® 2.5, AstraZeneca) for weight variation, hardness, thickness, diameter, friability, wetting time, disintigration time, drug content, cumulative drug release and result revealed that formulated mouth dissolving tablets of Zolmitriptan were effective and better to meet patient compliance. Hence, comparative study shows that optimized formulation gives more efficiency, also all near about all physicochemical properties are passes I.P. limit and good cumulative Drug releasing than marketed preparation.

Table 4: Comparison of % CDR between Marketed Formulation and Optimized Batch

Time (min)	Optimized batch (F7)	Marketed Formulation
0	0	0
1	34.16	15.12
2	44.47	34.44
3	79.1	42.32
4	82.83	55.69
5	89.07	70.11
6	99.24	79.24

Figure 6: Comparison between marketed formulation and optimized Batch (F7)

Table 5: Comparative parameters between marketed formulation and optimized Batch

No.	Parameter	Optimized Batch (F7)	Marketed formulation
1	Weight Variation (%)	3.1	6.6
2	Thickness (mm)	4.5±0.015	4.4±0.15
3	Diameter (mm)	5.1±0.015	5.3±0.015
4	Friability (%)	0.45±0.061	2.90±0.22
5	Wetting time (min)	0.31±0.33	60.1±0.22
6	Hardness (Kg/cm²)	2.5±0.3055	7.42±0.46
7	Disintigration time (Min)	0.30±0.177	1.54±0.48
8	Drug Content (%)	94.44 ± 0.71	87.03±0.75
9	% CDR (at time of 6 min)	99.24	79.24

Optimization studies:

A 3² full factorial design was selected and the 2 factors were evaluated at 3 levels, respectively. The percentage of CCS i.e. croscarmellose sodium (X₁) and MCC i.e. Microcrystalline cellulose (X₂) were selected as independent variables and the dependent variables were % cumulative drug release_.The data obtained were treated using Design expert version 8.0.4.1 software and analyzed statistically using analysis of variance (ANOVA). The data were also subjected to 3-D response surface methodology to study the interaction of Croscarmellose Sodium (X₁) and microcrystalline cellulose (X₂) on dependent variable. The ANOVA for the dependent variable is shown as % cumulative drug release. The values of X1 and X2 were found to be significant at p <0.05, hence confirmed the significant effect of both the variables on the selected responses.

Final Equation in Terms of Actual Factors;

Y= 93.13-1.65*A + 5.12*B Where, A= CCS, B=MCC

Table 6: Analysis of variance for % CDR

Source	F Value	p-value Prob> F	Model significant/non significant	Standard Deviation	R-Squared
Model	78.99	0.0001	Significant	1.05	0.9634
A- CCS	14.61	0.0084
B- MCC	143.06	0.0001

Table 7: Design Summary

Factors	Name	Units	Type	Min.	Max.	-1 actual	+1 actual	Mean	Std. Dev.
A	CSS	Mg	Numeric	20	60	-1.00	1.00	40	15.492
B	MCC	Mg	Numeric	20	40	-1.00	1.00	30	7.746

CCS = Croscarmellose Sodium, MCC = Microcrystalline cellulose

Figure 9: Perturbation plot of % CDR

Table 8: Response Summary

Response	Name	Units	Obs.	Analysis	Minimum
Y1	% CDR	%	9	Polynomial	86.00
Maximum	Mean	Std. Dev.	Ratio	Trans	Model
99.240	93.132	4.473	1.154	None	Linear

CONCLUSION:

In the present work, an attempt was made to develop mouth dissolving tables of Zolmitriptan as an improved and better patient compliance dosage form. From the study conducted and from the observations and results obtained thereof following conclusions were drawn:

 FTIR studies concluded that drug and excipients were compatible with each other.

 The formulated tablets were satisfactory in terms of hardness, thickness, friability, weight variation, drug content uniformity, wetting time, disintigration time, and in-vitro drug release.

 Formulation containing (Croscarmellose Sodium 60 mg and microcrystalline cellulose 20 mg) showed least disintigration time, least wetting time, and highest cumulative drug release and highest drug content. Hence, from the study, formulations the optimum batch from is selected which depend upon the several factors such as less friability, less disintegration time. Not much variation or change was observed in any parameters throughout the study period. Best-selected formulation F7 found to be stable. The prepared mouth dissolving tablets disintegrate in seconds without need of water and enhance the absorption; this leads to increase in the bioavailability of Zolmitriptan.

 The final optimized formulation (F7) of Zolmitriptan containing natural superdisintegrant was compared to marketed conventional tablet of Zolmitriptan (Zomig® 2.5, AstraZeneca) and result revealed that formulated Orodispersible tablets of Zolmitriptan were effective and better to meet patient compliance.

 In present study Hydrophilic Disintegrating agent also suspending agent Xanthan gum which is also gives mucoadhesiovness so avoid hepatic metabolism and Microcrystalline cellulose increase comparable dissolution profile over the Croscarmellose Sodium, lactose, Magnesium stearate, mannitol. For mouth dissolving Tablets, xanthan gum obtained was biodegradable, directly compressible and exhibited desirable swelling dynamics to be used as a hydrophilic excipient for rapidly disintegrating tablets. The mouth dissolving tablets formulated with lower level of xanthan gum (1.5 mg) and higher level of croscarmellose sodium (60 mg) was selected as the optimized formulation that displayed nine fold reductions in lag time, was stable for a period of 12 months and retained the rapid disintegration characteristics till the end of tested time period.

 Hence, it proofs success of natural mucoahesive agent in mouth dissolving tablets formulation at very low concentration and cost can be used. The bitter taste of drug was also masked hence, administration of mouth dissolving tablet became easy.

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Received on 07.07.2016 Accepted on 18.09.2016

Asian J. Pharm. Tech. 2016; 6(4): 207-216.

DOI: 10.5958/2231-5713.2016.00031.3

Month Test	Before stability testing	1 Month	2 Month	3 Month
Colour	Off white	Off white	Off white	Off white
Odour	None	None	None	None
Hardness (Kg/cm²)*	2.5±0.3055	2.5±0.3055	2.350.3051	2.90.3151
Disintegration Time (min)*	0.30±0.177	0.30±0.177	0.330.0435	1.390.0436
Drug Content (%)*	99.44±0.71	99.40±0.71	99.300.115	98.190.049
% Drug Release*	99.24	99.24	99.12	98.01