Design and Evaluation of Meloxicam Mouth Dissolving Tablets

K Sreenivasa Rao¹*, Maajid Khan¹, Dattatraya Udgirkar¹, Praveen S Patil¹, Karnakumar V Biradar²

¹Department of Pharmaceutics, RRKS College of Pharmacy, Bidar-585402, India

²Department of Pharmacology, RRKS College of Pharmacy, Bidar-585402, India

*Corresponding Author E-mail: bidarkaran@gmail.com

ABSTRACT:

In the present study, Mouth dissolving tablets of Meloxicam were designed with a view to enhance patient compliance. Meloxicam, a new non-steroidal anti-inflammatory agent mainly used for the treatment of osteoarthritis and rheumatoid arthritis. However, it may cause gastro-intestinal tract disturbances/induce ulcer to avoid these complications we designed Mouth dissolving tablets of Meloxicam. The prepared batches of Mouth dissolving tablets were evaluated for hardness and friability, drug dispersion time, drug content uniformity, wetting time, water absorption ratio and in vitro dispersion time. Based on in vitro dispersion time (approximately 8-30 s), all formulations were tested for in vitro drug release pattern (in Phosphate buffer), Short-term stability (40⁰C/ 75% RH for 3 months) and drug-excipient interaction study (IR spectroscopy). Among all the formulations, the formulation prepared by 6% sodium starch glycolate was found to have minimum dispersion time (8.77 s) and Short-term stability studies on the promising formulation indicated that there were no significant changes in drug content and in vitro dispersion time.

KEYWORDS: Mouth dissolving tablets (MDT), Novel drug delivery systems (NDDS) Meloxicam, Sodium Starch Glycolate, Croscarmellose sodium.

INTRODUCTION:

Tablets are the most widely used and accepted dosage forms. Some geriatric patients and patients suffering with motion sickness find difficulty in swallowing. This may result in high incidence of non- compliance and ineffective therapy ¹. In recent times many novel drug delivery systems have been formulated for improving safety, efficacy and patient compliance. One of such NDDS which is of current interest is mouth dissolving (MDT) or fast dissolving tablets (FDT) ².Osteoarthritis and Rheumatoid arthritis is the inflammation that leads to the common symptoms of pain, tenderness and swelling associated with arthritis due to over synthesis of prostaglandins level within the joints.

Meloxicam having Molecular Formula C₁₄H₁₃N₃O₄S_2, is a class of nonsteroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and/or inflammation through blocks the enzymes (cyclooxygenase 1 and 2) and reduces the levels of prostaglandins.

MATERIALS AND METHODS:

Material used:

Pharma grade Meloxicam (Aurbindo Pharma Ltd., Hyd), Sodium starch glycolate (Signet Chemical Corp., Mumbai), Croscarmellose sodium ( Signet Chemical Corp., Mumbai), Microcrystalline cellulose (Avicel) (Signet Chemical Corp., Mumbai), Aspartame (Aurbindo Pharma Ltd., Hyderabad), Cherry flavor(Aurbindo Pharma Ltd., Hyd.),and L.R. grade Mannitol, Magnesium stearate, Potassium dihydrogen orthophosphate (S.D. Fine Chem. Ltd.).

Instruments and equipment used:

Digital balance (Citizen CTG–302), Hardness tester (Monsanto), Friability test apparatus(Electro lab USP EF₂)_, Hydraulic press(Clit pilot press), Vernier caliper (Pico India Ltd), dissolution tester (USPXX IV)Tablet(Electro Lab), Tap density tester(K. E. India), UV Spectrophotometer (Shimadzu 1800), FTIR Spectrophotometer (Shimadzu -8400 S), pH meter (Hanna Instruments, Italy) Humidity chamber (Thermo Lab.).

Table No.1: Composition of different batches of mouth dissolving tablet of Meloxicam

Ingredients (mg/tab)	Formulations Code
	F0	F1	F2	F3	F4	F5	F6	F7	F8
Meloxicam	7.5	7.5	7.5	7.5	7.5	7.5	7.5	7.5	7.5
Sodium starch glycolate	-	2	4	6	8	-	-	-	-
Croscarmellose (CS)	-	-	-	-	-	2	4	6	8
Mannitol	20	20	20	20	20	20	20	20	20
Sil Dioxide	2	2	2	2	2	2	2	2	2
Magnesium stearate	1	1	1	1	1	1	1	1	1
Sod Saccharin	1	1	1	1	1	1	1	1	1
Flavour (Mixed Fruite)	4	4	4	4	4	4	4	4	4
M.C.C	114.5	112.5	110.5	108.5	106.5	112.5	110.5	108.5	106.5
Total weight	150	150	150	150	150	150	150	150	150

F₀- Meloxicam (MDT) without superdisintegrant, F₁ to F₄- Meloxicam (MDT) with sodium starch glycolate superdisintegrant, F₅ to F₈- Meloxicam (MDT) with Croscarmellose sodium superdisintegrant

Formulation of Mouth dissolving tablet of Meloxicam:

Mouth dissolving tablets of Meloxicam were prepared by direct compression according to the formulae given in the table 1. All the ingredients were passed through # 60 mesh sieve separately. The drug and micro crystalline cellulose (MCC) were mixed by adding small portion of each at a time and blending it to get a uniform mixture and kept aside. Then the other ingredients were mixed in geometrical order and passed through coarse sieve (#44 mesh) and the tablets were compressed using hydraulic press. Compression force of the machine was adjusted to obtain the hardness in the range of 3-4 kg/cm² for all batches. The weight of the tablets was kept constant for all formulations F_0Yto F₈ (150mg).

Evaluation of mouth dissolving tablets:

Pre-compression parameters:

Pre- formulation studies like Bulk Density (D_b), Tapped density (D_t), Angle of Repose (q), Compressibility Index and Hausner’s Ratio was performed to assess the physicochemical properties.

Post-compression parameters:

Shape of Tablets:

Directly compressed tablets were examined under the magnifying lens for the shape of the tablet.

Tablet Dimensions:

Thickness and diameter were measured using a calibrated vernier caliper. Three tablets of each formulation were picked randomly and thickness was measured individually.

Hardness:

The hardness of the tablets was determined using Monsanto hardness tester. It is expressed in kg/cm². Three tablets were randomly picked and hardness of the tablets was determined ³.

Friability test:

The friability of tablets was determined by using electrolab friabilator. It is expressed in percentage (%). Ten tablets were initially weighed (W_I) and transferred into friabilator. The friabilator was operated at 25 rpm for 4 minutes or run up to 100 revolutions. The tablets were weighed again (W_F). The % friability was then calculated using formula

%F = 100 (1-W_I/W_F)

% Friability of tablets less than 1% was considered acceptable ³.

Weight Variation Test:

Ten tablets were selected randomly from each batch and weighed individually to check for weight variation. The following percentage deviation in weight variation was allowed³.

Average weight of a tablet	Percentage deviation
130 mg or less	±10
>130mg and <324mg	±7.5
324 mg or more	±5

In all formulations, the tablet weight is 150 mg, hence 7.5% maximum difference allowed.

Test for drug Content Uniformity:

Tablet containing 7.5mg of drug was dissolved in 50ml of distilled water taken in volumetric flask. The drug was allowed to dissolve in the solvent. The solution was filtered, 2ml of filtrate was taken in 10ml of volumetric flask and diluted up to mark with distilled water and analyzed spectrophotometrically at 269nm. The concentration of Granisetron hydrochloride was obtained by using standard calibration curve of the drug. Drug content studies were carried out in triplicate for each formulation batch ⁴.

Wetting Time and Water Absorption Ratio:

A piece of tissue paper folded twice was kept in culture dish (internal diameter 5.5 cm) containing 6 ml of distilled water. A tablet having a small of amaranth powder on the upper surface was placed on the tissue paper. The time required to develop a red color on the upper surface of the tablet was recorded as wetting time ⁵. The same procedure without amaranth was followed for determining water absorption ratio. The wetted tablet was then weighed and the water absorption ratio ‘R’ was determined by using following equation-

R = W_b – W_a x 100

W_a

Where,

W_a = weight of tablet before water absorption

W_b = weight of tablet after water absorption.

Table No. 2: Pre-Compression Parameters of all Formulations

Formulations	Bulk density* (g/cc)	Tapped density* (g/cc)	Angle of repose* (θ)	Compressibility Index (%)	Hausner’s ratio
F0	0.441	0.542	31^0.46′	22.90	1.22
F1	0.422	0.575	30^0.45′	23.1	1.36
F2	0.40	0.483	29^0.72′	17.18	1.20
F3	0.425	0.524	29^0.03′	18.89	1.23
F4	0.412	0.505	28^0.45′	18.41	1.22
F5	0.419	0.510	27^0.87′	17.84	1.21
F6	0.387	0.457	28^0.59′	19.03	1.18
F7	0.379	0.453	29^0.16′	16.33	1.19
F8	0.394	0.478	29^0.33′	17.57	1.21

*mean± SD, n=3

In vitro Dispersion Time:

Tablet was added to 10ml of distilled water at 37±0.5⁰C. Time required for complete dispersion of a tablet was measured ⁶.

In vitro Dissolution Study:

In vitro dissolution of Meloxicam mouth dissolving tablets was studied in USP XXIV dissolution test apparatus. 900ml Phosphate buffer 6.8(simulated fluid) was used as dissolution medium. The stirrer was adjusted to rotate at 75rpm. The temperature of dissolution medium was maintained at 37±0.5ºC throughout the experiment. One tablet was used in each test. Samples of dissolution medium (5ml) were withdrawn by means of syringe fitted with pre-filter at known intervals of time and analyzed for drug release by measuring the absorbance at 269nm. The volume withdrawn at each time interval was replaced with fresh quantity of dissolution medium. Cumulative percent of Meloxicam released was calculated and plotted against time ⁷.

Stability studies:

The selected formulation was packed in amber-colored bottles, which were tightly plugged with cotton and capped. They were then stored at 40⁰C / 75 % RH for 3 months and evaluated for their physical appearance, drug content and in vitro dispersion time at specified intervals of time.

RESULTS AND DISCUSSION:

Evaluation of mouth dissolving tablets:

Pre-compression Parameters:

Bulk Density:

The values obtained for bulk density for all (F₀-F₈) formulations are tabulated in Table 2. The values were found to be in range of 0.379 to 0.441 gm/cm³.

Tapped Density:

The values obtained for Tapped density for all (F₀-F₈) formulations are tabulated in Table 2. Tapped density ranges from 0.453 to 0.575 gm/cm³.

Angle of Repose (q):

The values were found to be in the range from 27⁰ - 31⁰, tabulated in Table 2. This indicates good flow property of the powder blend.

Compressibility Index:

Compressibility index value ranges between 16. 33%- 23.10%, tabulated in Table 2, indicating that the powder blends have the required flow property for direct compression.

Hausner’s Ratio:

The values were found to be in the range from 1.18– 1.36, tabulated in Table 2.

Post-compression Parameters:

Shape of the tablet:

Microscopic examination of tablets from each formulation batch showed circular shape with no cracks.

Tablet dimensions:

The dimensions determined for formulated tablets are tabulated in Table 3. Tablets mean thicknesses were almost uniform in all the formulations and were found to be in the range of 2.78 mm to 2.80 mm. The diameter of the tablet ranges between 8.00 mm to 8.03 mm.

Hardness test:

The measured hardness of tablets of each batch ranged between 3 kg/cm² to 4 kg/cm² and was tabulated in Table 3. Tablet hardness was increased as increasing the compression force. This ensures good handling characteristics of all batches.

Friability Test:

The values of friability test are tabulated in Table 3. The % friability was less than 1% in all the formulations ensuring that the tablets were mechanically stable.

Weight Variation Test:

The percentage weight variation for all formulations was shown in Table 3. All the tablets passed weight variation test as the % weight variation was within the pharmacopoeial limits. The weights of all the tablets were found to be uniform with low standard deviation values.

Drug Content Uniformity:

The percentage of drug content was found to be between 95.29 to 99.92 of Meloxicam, which was within acceptable limits. Table 4 showed the results of drug content uniformity in each batch.

Table No. 3: Physical Properties of Mouth dissolving Tablets of all Formulations

Formulations	Diameter* (mm)	Thickness* (mm)	Weight variation* (mg)	Hardness* (kg/cm^2)	Friability (%)
F0	8.01±0.049	2.80±0.008	200.1±1.29	3.31±0.2	0.295
F1	8.02±0.041	2.79±0.007	201.2±1.40	3.38±0.3	0.395
F2	8.01±0.051	2.80±0.009	199.8±1.84	3.32±0.2	0.335
F3	8.02±0.052	2.78±0.010	199.5±1.80	3.41±0.1	0.280
F4	8.03±0.031	2.79±0.011	201.3±1.12	3.35±0.3	0.624
F5	8.00±0.029	2.79±0.007	200.8±1.74	3.36±0.5	0.298
F6	8.01±0.051	2.80±0.006	200.5±1.92	3.32±0.4	0.445
F7	8.00±0.043	2.78±0.007	200.4±1.81	3.41±0.5	0.336
F8	8.02±0.052	2.79±0.009	199.2±1.24	3.39±0.5	0.552

*mean ±SD, n=3

Table No. 4: Post Compression Parameters of Mouth dissolving Tablets of all Formulations

Formulations	Wetting time* (in sec)	Water absorption ratio* (in sec)	In vitro dispersion time* (in sec)	Drug content* (%)
F0	172.2±1.88	55.6±0.885	80.55±5.25	94.29±0.369
F1	92.2±1.78	59.77±0.95	15.22±1.33	95.95±0.255
F2	86.3±1.75	61.25±0.55	11.35±1.29	98.99±0.356
F3	78.21±2.25	66.66±1.009	8.77±3.55	99.55±0.482
F4	70.6±3.21	66.0±0.525	12.25±1.147	99.25±0.429
F5	68.4±2.92	57.8±0.715	21.20±2.089	99.77±0.526
F6	63.22±3.77	58.2±0.35	18.15±0.905	97.92±0.675
F7	58.4±6.27	59.97±0.49	24.36±1.275	98.15±0.195
F8	52.52±1.95	60.85±0.92	25.38±0.662	99.64±0.259

*mean ±SD, n=3

In vitro Dispersion Time:

The most important parameter that needs to be optimized in the development of Mouth dissolving tablets is the dispersion time in tablets. In the present study, all the tablets dispersion in ≤ 30 sec fulfilling the official requirement (<3 sec.) for dispersible tablets.

The in vitro dispersion times for all formulations are shown in Table 4. The tablets prepared by using superdisintegrants like sodium starch glycolate, croscarmellose shown in vitro dispersion time between 8.77-15.22 sec, 18.15-25.38 sec. respectively. The in vitro dispersion time for control formulation was found to be 80.55 sec. All the formulations had dispersion time of less than 30 sec. Among the two superdisintegrants SSG showed the highest efficiency. Formulations containing 6% w/w SSG (F₃) showed the least dispersion time of 8.77±3.55 sec, when compared with CS. The concentration of superdisintegrants also effect dispersion time. In case of SSG, CS, concentration higher than 6% w/w shows increase in dispersion time. So it may be assumed that 6% w/w concentration is optimum for SSG, CS. Such a behavior of superdisintegrants at higher concentration may be due to the blockade of capillary pores which prevents the entry of fluid into the tablet.

Wetting Time:

The wetting time for all formulations is shown in Table 4. The tablets prepared by using different superdisintegrants like Sodium starch glycolate, Croscarmellose shown wetting time between 70.6-92.2 sec and 52.5-68.4 sec. respectively. The wetting time for control formulation was found to be 172.2 sec. As the concentration of superdisintegrants was increased, the wetting time is reduced.

Water Absorption Ratio:

The water absorption ratio for all formulations is shown in Table 4. The tablets prepared by using superdisintegrants like Sodium starch glycolate and Croscarmellose shown water absorption ratio between 59-77- 66.66 and 57.80- 60.85 respectively. The wetting time for control formulation was found to be 55.6 sec. From the observations, it is evident that water absorption ratio or water uptake of superdisintegrants follows the order SSG>CS. There was a linear increase in water uptake with increase in concentration of superdisintegrants. This was in contrast to dissolution rate, which decreases with increase in concentration.

In vitro Dissolution Study:

The in vitro drug release study of Mouth dissolving tablets from each batch (F₀ to F₈) was carried out in phosphate buffer 6.8(simulated fluid) for 30 min. and the values are shown in Table 5 to 14.

The plot of % Cumulative drug release V/s time (min.) were plotted and depicted as shown in Fig 1 to 2. From the in vitro dissolution data, it was found that the drug release study from formulations containing Sodium starch glycolate (F₁-F₄) was 40.90%, 64.24%, 99.35% and 89.61% drug release respectively. Formulations containing Croscarmellose sodium (F₅-F₈) showed 75.97%, 81.81%, 95.47%, and 87.66% respectively. While the formulation without superdisintegrants (F₀) showed 37.01%.

Figure no.1. In vitro drug release profile of Meloxicam (F₀) and Meloxicam with Sodium starch glycolate (F₁-F₄) Formulation

It was observed from the results that, SSG formulations showed maximum dissolution rate with more than 99.35% of drug release in 30 min. The concentration of superdisintegrants in the formulations also increased the dissolution rate. In all the formulations SSG 6% w/w concentration, there was linearly increase in dissolution rate.

Figure no.2. In vitro drug release profile of Meloxicam (F₀) and Meloxicam with Croscarmellose sodium (F_5- F₈₎ Formulation

Table No. 5: In vitro drug release profile of F₀ Formulation

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.012	0.285714	0.257429	23.37662	1.368782	76.62338
10	0.013	0.309524	0.278881	25.32468	1.403544	74.67532
15	0.014	0.333333	0.300333	27.27273	1.435729	72.72727
20	0.016	0.380952	0.343238	31.16883	1.493721	68.83117
25	0.017	0.404762	0.36469	33.11688	1.520049	66.88312
30	0.019	0.452381	0.407595	37.01299	1.568354	62.98701

mean±SD, n=3

Table No. 6: In vitro drug release profile of F₁ Formulation (2% SSG)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.015	0.357143	0.321786	29.22078	1.465692	70.77922
10	0.016	0.380952	0.343238	31.16883	1.493721	68.83117
15	0.017	0.404762	0.36469	33.11688	1.520049	66.88312
20	0.019	0.452381	0.407595	37.01299	1.568354	62.98701
25	0.020	0.47619	0.429048	38.96104	1.590631	61.03896
30	0.021	0.5	0.4505	40.90909	1.61182	59.09091

*mean±SD, n=3

Table No. 7: In vitro drug release profile of F₂ Formulation (4% SSG)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.016	0.380952	0.343238	31.16883	1.493721	68.83117
10	0.019	0.452381	0.407595	37.01299	1.568354	62.98701
15	0.023	0.547619	0.493405	44.80519	1.651328	55.19481
20	0.026	0.619048	0.557762	50.64935	1.704574	49.35065
25	0.028	0.666667	0.600667	54.54545	1.736759	45.45455
30	0.033	0.785714	0.707929	64.28571	1.808114	35.71429

*mean±SD, n=3

Table No. 8: In vitro drug release profile of F₃ Formulation (6% SSG).

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.032	0.761905	0.686476	62.33766	1.79475	37.66234
10	0.035	0.833333	0.750833	68.18182	1.833669	31.81818
15	0.037	0.880952	0.793738	72.07792	1.857802	27.92208
20	0.042	1	0.901	81.81818	1.91285	18.18182
25	0.048	1.142857	1.029714	93.50649	1.970842	6.493506
30	0.051	1.214286	1.094071	99.35065	1.997171	0.649351

*mean±SD, n=3

Table No. 9: In vitro drug release profile of F₄ Formulation (8% SSG).

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.026	0.619048	0.557762	50.64935	1.704574	49.35065
10	0.032	0.761905	0.686476	62.33766	1.79475	37.66234
15	0.037	0.880952	0.793738	72.07792	1.857802	27.92208
20	0.039	0.928571	0.836643	75.97403	1.880665	24.02597
25	0.04	0.952381	0.858095	77.92208	1.891661	22.07792
30	0.046	1.095238	0. 89681	89.61039	1.952358	10.38961

*mean±SD, n=3

Table No. 10: In vitro drug release profile of F₅ Formulation (2% CS)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.023	0.547619	0.493405	44.80519	1.651328	55.19481
10	0.025	0.595238	0.53631	48.7013	1.687541	51.2987
15	0.027	0.642857	0.579214	52.5974	1.720964	47.4026
20	0.029	0.690476	0.622119	56.49351	1.751999	43.50649
25	0.031	0.738095	0.665024	60.38961	1.780962	39.61039
30	0.039	0.928571	0.836643	75.97403	1.880665	24.02597

*mean±SD, n=3

Table No. 11: In vitro drug release profile of F₆ Formulation (4% CS)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.025	0.595238	0.53631	48.7013	1.961852	51.2987
10	0.029	0.690476	0.622119	56.49351	1.751999	43.50649
15	0.03	0.714286	0.643571	58.44156	1.766722	41.55844
20	0.032	0.761905	0.686476	62.33766	1.79475	37.66234
25	0.036	0.857143	0.772286	70.12987	1.845903	29.87013
30	0.042	1	0.901	81.81818	1.91285	18.18182

*mean±SD, n=3

Table No. 12: In vitro drug release profile of F₇ Formulation (6% CS)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.029	0.690476	0.622119	56.49351	1.751999	43.50649
10	0.032	0.761905	0.686476	62.33766	1.79475	37.66234
15	0.037	0.880952	0.793738	72.07792	1.857802	27.92208
20	0.04	0.952381	0.858095	77.92208	1.891661	22.07792
25	0.044	1.047619	0.943905	85.71429	1.933053	14.28571
30	0.049	1.166667	1.051167	95.45455	1.979797	4.545455

*mean±SD, n=3

Table No. 13: In vitro drug release profile of F₈ Formulation (8% CS)

Time (mins)	Abs*	Conc. (µg/ml)	CDR (mg)	CDR (%)	Log % CDR	Cumulative % drug remained
0	0	0	0	0	-	100
5	0.028	0.666667	0.000667	54.54545	1.736759	45.45455
10	0.032	0.761905	0.686476	62.33766	1.79475	37.66234
15	0.036	0.857143	0.772286	70.12987	1.845903	29.87013
20	0.039	0.928571	0.836643	75.97403	1.880665	24.02597
25	0.043	1.02381	0.922452	83.76623	1.923069	16.23377
30	0.045	1.071429	0.965357	87.66234	1.942813	12.33766

mean±SD, n * =3

Table No. 14: In vitro% drug release for all Meloxicam Mouth dissolving tablet formulations

Time (mins)	Formulations Code
	F0	F1	F2	F3	F4	F5	F6	F7	F8
5	23.37	29.22	31.16	62.33	50.64	44.80	48.70	56.49	54.54
10	25.32	31.16	37.01	68.18	62.33	48.70	56.49	62.33	62.33
15	27.27	33.11	44.80	72.07	72.07	52.59	58.44	72.07	70.12
20	31.16	37.01	50.64	81.81	75.97	56.49	62.33	77.92	75.97
25	33.11	38.96	54.54	93.50	77.92	60.38	70.12	85.71	83.76
30	37.01	40.90	64.28	99.35	89.61	75.97	81.81	95.45	87.66

F₀- Meloxicam (MDT) without superdisintegrant, F₁ to F₄- Meloxicam (MDT) with sodium starch glycolate superdisintegrant, F₅ to F₈ Meloxicam (MDT) with Croscarmellose sodium superdisintegrant

Stability Studies:

The selected formulation was evaluated for stability studies and results were shown in the Table No. 15 and it was found to be within the permissible limits.

Table No 15: Stability data of F₃ formulation

Time in months	Formulation F3 stored at 40^0C / 75% RH
	Physical appearance	In vitro Dispersion time	% Drug content
1	+++	8.96	99.10
2	+++	9.25	98.42
3	++	9.95	96.99

+++ = Same as on zero day, ++ = Slight change in color, F₃ Meloxicam (MDT) with sodium starch glycolate superdisintegrant(6% SSG).

CONCLUSION:

In the present work, mouth dissolving tablets of Meloxicam were prepared by direct compression method using superdisintegrants such as Sodium Starch Glycolate and Croscarmellose sodium. The flow properties of polymer and drug were good, FT-IR studies revealed that there is no chemical interaction between Meloxicam and the excipients used in the study, the tablets prepared were found good without any chipping, capping and sticking. Formulated tablets gives satisfactorily result for various physico-chemical evaluation of tablets like tablet dimension, hardness, friability, weight variation, in vitro dispersion time, wetting time, water absorption ratio and drug content.

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Received on 10.04.2014 Modified on 15.06.2014

Accepted on 15.07.2014 ©A&V Publications All right reserved

Res. J. Pharm. Dosage Form. & Tech. 7(1): Jan.-Mar. 2015; Page 44-50

DOI: 10.5958/0975-4377.2015.00007.5