Formulation, Development and Evaluation of Famotidine Orodispersible Tablets

Pallavi P. Ahire*, Yashpal M. More, Vinay R. Kothawade

Loknete Dr. J. D. Pawar College of Pharmacy, College in Manur, Maharashtra.

*Corresponding Author E-mail: pallaviahire022@gmail.com

ABSTRACT:

Aim of the study: The main objective of present research work is to formulate the famotidine orodispersible tablets. Famotidine is a selective H2 receptor antagonist or H2 blocker belongs to BCS Class-II and is used to treat heartburn and duodenal ulcers. Materials and methods: The Orodispersible tablets of famotidine were prepared employing different concentrations of sodium starch glycolate, Crospovidone and Croscarmellose sodium in different combinations as superdisintegrants by direct compression. Mannitol and sodium saccharine were added to microcrystalline cellulose Magnesium stearate as a diluent to improve the organoleptic qualities of the tablets. using 2³ factorial design mothod was used to formulate orodispersible tablet. Prepared tablets were then subjected to different tests for tablets like Wetting time, Water absorption ratio in-vitro disintegration time, thickness, diameter, hardness, friability, weight variation, drug content, and in-vitro dissolution study were all assessed for the tablets. Design expert study was conducted to know the interaction between different superdisintegrants and to select best optimized formulation in among all formulations. Results: The tablets' good mechanical strength was indicated by the hardness and friability data. The tablets quickly dispersed in the mouth in less than 12 seconds, according to the F5 in vitro disintegration time results respectively, and 99.24% of the drug release in 15 minutes. The optimal formulations of Famotidine Orodispersible tablets for enhancing the drug's bioavailability and onset of action were determined to be F5. Conclusion: The optimized formulation showed increased drug release compared to commercially available orodispersible tablets. No changes in disintegration time, drug content and in in vitro drug release from optimized formulation on storage for 1months at 40°C ± 2°C /75% RH ± 5% RH were observed during stability studies which confirmed the stability of the optimized formulation.

KEYWORDS: Famotidine Orodispersible Tablets 2³ Factorial Design, Superdisintegrants, Sodium Starch Glycolate, Crospovidone, Croscarmellose Sodium, Disintegration Time, In-Vitro Drug Release.

INTRODUCTION:

It's a tablet that dissolves quickly in saliva and doesn't require chewing or drinking water in a matter of seconds. In the oral cavity, an orodispersible tablet typically dissolves in 15 to 3 minutes. Orodispersible tablets are also referred to as melt-in-mouth, rapimelts, porous tablets, fast dissolving, mouth-dissolving, and rapid dissolving tablets. They have the unusual ability to dissolve and release the medication quickly when they come into contact with saliva, negating the need for water during administration. They also transform into a soft paste or liquid form that is easy to swallow and poses no choking hazard.^1.

Super disintegrants like croscarmellose sodium, sodium starch glycolate, and crosspovidone are mostly used in the preparation of these tablets. Super disintegrants are incorporated into this formulation to facilitate the tablet's disintegration into smaller particles, resulting in a quicker onset of action. The majority of quickly dissolving tablets need to contain ingredients to cover up the bitter flavour of the active ingredient. The patient's saliva then swallows the masked active ingredient along with the soluble and insoluble excipients. It has been determined that the absorption, onset of action, and dissolution rates all increase with speed. As saliva travels down into the stomach, some medications are absorbed from the mouth, throat, and oesophagus, avoiding the first pass metabolism. As a result, the drug's bioavailability is much higher than that of standard tablet dosage forms.²

ODT dissolves and disintegrates primarily due to the action of super disintegrants. Super disintegrants have a rapid disintegration rate because of the formulation's porous structure, which is formed by both swelling and water absorption. The critical disintegrant concentration can be used to determine the ideal superdisintegrant concentration. When the superdisintegrant concentration is above the critical concentration, the disintegration time stays nearly constant or even increases. Below this concentration, the tablet disintegration time is inversely proportional to the superdisintegrant concentration.

An antagonist of the H2 receptor is famotidine. an H2 blocker with a thiazole ring that binds firmly to H2 receptors and has a longer half-life even after elimination. After taking it orally, famotidine starts to work within an hour and inhibits stomach secretion for the following 10 to 12 hours. Metabolic and renal pathways are used for elimination. Therefore, it's critical to lower the medication dosage for patients who have renal or kidney failure. In addition to reducing basal and food-stimulated acid secretion by 90% or more, famotidine also speeds up the healing of duodenal ulcers. Its short elimination half-life of three hours is attributed to its poor absorption from the lower gastrointestinal tract. The drug's 0.1% w/v aqueous solubility at 20°C causes challenges in dosage form formulation, resulting in varying rates of dissolution.^3,4

MATERIALS AND METHODS:

Materials:

Famotidine was obtained from Balaji drug limited sodium starch glycolate, Croscarmellose (Ac-di-sol) (Super disintegrant), Manitol (Sweetning agent), Sodium Saccharine (Flavouring agent), Aerosil (Glidant), Magnesium Stearate (Lubricant) are purchases from Modern Chemical industries-sinnar Crospovidone (Super disintegrant), Microcrystalline cellulose (Binder) are purchases from Research lab fine chem industries, Mumbai.⁵

Methods:

Preformulation study

A. Ultra violet spectroscopy:

Determination of Analytical Wavelength (λmax):

A standard stock solution of Famotidine was prepared by dissolving accurately weighed 10mg of Famotidine in water in a 100ml volumetric flask and the volume was made up to 100ml with water to obtain a stock solution of 100µg/ml. From the standard stock solution, 2.5ml was pipetted into 10ml volumetric flask. The volume was made up to 10ml with water. The resulting solution containing 10µg/ml was scanned between 200 and 400 nm.

B. Drug-excipient compatibility study:

FTIR and DSC:

Drug-excipient compatibility study carried out by using FTIR and DSC analysis. FTIR spectra of all formulations were obtained on IR-Spectrophotometer (Brunker) wavelength range of 4000-400 cm^-1 has been determined. DSC thermogram was obtained by using (Shimadeu DSC-60plus) instrument with temperature ranging from 100 to 300ºC.

Preparation of famotidine orodispersible tablet by direct compression method:

Accurate quantity of drug and all ingredients were weighed according to formula and powder except Aerosil and Magnesium sterate was blended homogeneously in mortor and pestle for 15 minutes. Prepared powder blend was passed through sieve no. #60. Finally, Aerosil and Magnesium sterate passed from sieve no. #30 added and was further mixed for 10 minutes.

Accurately weighed 200 mg homogeneously mixed powder blend was fed manually and compressed with constant compression force and hardness on Cadmach tablet compression machine with 8 mm, breakthrough, and flat faced punches. Total nine formulations were prepared.⁶

Experimental Design:

Experimental design is a systematic and scientific approach to study the relationship and interaction between independent and dependent variables. 2³ full factorial design was implied for optimizing the formulations. The selected design offers adequate degree of freedom to determine main effects of individual factors as well as factor interactions.

Table 1: Composition of independent variables and their levels for the preparation of famotidine orodispersible tablet

Sr. No.	Independent factor	Unit	Low (-1)	High (+1)
1	Croscarmellose sodium	mg	4	8
2	sodium starch glycolate	mg	4	8
3	crospovidone	mg	4	8

Table 2: 2³ full factorial design for formulation designed using Stat-Ease Design-Expert® soft-ware (Version 8.0.7.1)

Formulations	F1	F2	F3	F4	F5	F6	F7	F8
Famotidine	20	20	20	20	20	20	20	20
sodium starch glycolate	4	8	4	4	8	4	8	8
Croscarmellose	4	4	8	8	8	4	8	4
Crospovidone	4	8	4	8	8	8	4	4
Mannitol	25	25	25	25	25	25	25	25
Microcrystalline cellulose	128	120	124	120	116	124	120	124
Sodium Saccharin	5	5	5	5	5	5	5	5
Aerosil	5	5	5	5	5	5	5	5
Magnesium stearate	5	5	5	5	5	5	5	5
Total	200 mg	200 mg	200 mg	200 mg	200 mg	200 mg	200 mg	200 mg

Three independent variables (factors), concentration of sodium starch glycolate (A), Croscarmellose Sodium (B), and crospovidone were chosen and assessed at two different levels: low (-1) and high (+1) considered as independent factors of disintegration time, and drug release were selected as dependent variables (responses). The range of factor was selected, in order to find out its impact on the responses or dependent variables. Data were analyzed using Design Expert® (version 8.0.7.1) software available from Stat-Ease Inc., Minneapolis, MN. Table 1 provides the details.

Evaluation:

pre-compression parameters:

1. Bulk Density (Db) and Tapped Density (Dt):

After being gently shaken to break up agglomerates, a suitable amount of powder from each formulation was added to a 10 mL measuring cylinder. Following the observation of the initial volume, the cylinder was allowed to descend under its own weight at intervals of two seconds, falling to a hard surface from a height of 2.5 cm. The tapping was kept up until the volume didn't change any more. The following formula was used to calculate the bulk density (Db) and the tapped bulk density (Dt).⁷

Weight of Powder

Db= ---------------------------------------

Volume of the packing

Weight of Powder

Dt= ---------------------------------------

Tapped Volume of the packing

2. Carr’s Index:

Carr's compressibility index was used to calculate the powder blend's compressibility index. Evaluating a powder's Db, Dt, and packing down rate is a straightforward test. The following is the Carr index formula.

Dt- Db

Carr’s = ---------------X 100

3. Hausner’s Ratio:

It can be expressed as follows and is found by comparing the bulk density to the tapped density:

Hausner’s Ratio = ---------

Where Db is the powder's bulk density and Dt is its tapped density.

4. Angle of repose:

The greatest angle that can exist between the surfaces of a powder pile and a horizontal plane is known as the angle of repose. The angle of repose can be used to calculate the frictional force in loose powder or granules using the following equation:

tan θ = h/r

Where r denotes the radius of the pile's base, h is the pile's height, and θ is the angle of repose.

Post-compression parameters:

1. Weight variation:

The average weight of twenty tablets was calculated after they were chosen at random. Subsequently, the weight of each tablet was measured and compared to the average weight.⁸

2. Hardness:

A Monsanto hardness tester was used to calculate the tablet crushing load, which is the force needed to break a tablet by compression in the radial direction.⁹

3. Friability:

The purpose of this test was to evaluate the effects of shock and friction. A preweighed sample of ten tablets was spun at 25 revolutions per minute for approximately four minutes in the Roche Friabilator. After the tablets were reweighed and dedusted, the friability percentage was computed using the formula. Weight loss from compressed tablets shouldn't exceed 1%.¹⁰

Initial weight of tablet – Final weight

Friability% = --------------------------------------------------

Initial weight of tablet

4. Thickness Test:

Placing the tablet between the two arms of the vernier callipers allowed for the measurement of thickness. A measurement was made of the thickness of five tablets_.

5. Disintegration Time Test:

Disintegration test equipment was used to calculate the in-vitro disintegration time. One disc was added to each of the apparatus's six tubes after a tablet was inserted into each tube. The duration in seconds required for the tablet to completely dissolve and leave no palatable mass inside the device was calculated.

6. Content Uniformity:

The percentage of the active ingredient in the tablet was ascertained using the UV Spectrophotometer method with the Famotidine ODTs in phosphate buffer (pH 6.8), in accordance with the range of Pharmacopoeia. Each batch's five tablets were weighed and ground into a powder. In order to create a stock solution, 20mg of equivalent weight of famotidine tablet powder was precisely weighed, dissolved in 100ml of phosphate buffer (pH 6.8) in a 100ml volumetric flask, sonicated for an hour, filtered, appropriately diluted, and tested for drug content at 265nm using a UV-Visible Spectrophotometer.¹¹

7. Wetting time of water absorption Ratio

An assessment of the intrinsic swelling and wettability of the super disintegrants can be made thanks to the wetting time characteristic of the loose disintegrant powder. A crucial factor that must be evaluated to provide insight into the tablet's disintegration characteristics is the ODT's wetting time; a lower wetting time indicates a faster tablet disintegration. Room temperature was used for the wetting period. Within a small 10cm-diameter petri dish with 6 ml of water, a piece of tissue paper folded twice was placed. The duration needed for water to reach the tablet's upper surface was measured while the tablet was placed on the paper. Removing the wet tablet from the petri dish, it was weighed to determine the water absorption ratio. Using the following formula, the water absorption ratio (R) was found.

R=100×Wa- Wb/Wb

8. In vitro Dissolution Studies:

The USP Type II Dissolution test apparatus was used to determine the dissolution profiles of famotidine tablets. The paddle speed was set to 50 rpm. Dissolution took place in 900 millilitres of pH 6.8 phosphate buffer that was kept at 37±5ºC. Five millilitres of the dissolution medium were extracted at 3, 6, 9, 12, and 15 minutes, with intervals of three minutes, and filtered through Whatmann filter paper. Using a UV-visible spectrophotometer, the amount of drug dissolved was calculated by measuring the sample's absorbance at 265 nm. To maintain the constant volume throughout the test, an equal volume of fresh medium pre-warmed at 37±5ºC was added to the dissolving medium after each sampling. Disso software was used to calculate the average percentage of drug release after three trials were completed for each batch.¹²

RESULTS AND DISCUSSION:

A. Standard Calibration curve of Famotidine in distilled water:

Accurately weighed quantity of Famotidine (10 mg) was dissolved in little quantity of distilled water and volume was made up to 100ml with the same (100 µg/ml). Then withdraw 0.5, 1, 1.5, 2, 2.5ml from the above solution in to separate 10 ml volumetric flasks and made up the volume to 10ml to produce 1, 2, 3, 4, 5µg/ml respectively. And the absorbances were taken at 265 nm. This procedure was performed in triplicate to validate the calibration curve.

B. Drug- excipient compatibility study:

Fourier Transform Infrared Spectroscopy (FTIR):

The FTIR spectra of pure drug and pure drug + excipient was taken and shown in figure 1 and 2 respectively.

Figure 1: Calibration Curve for Famotidine in Distilled Water

Figure 2: FTIR Spectra of Famotidine

These spectra revealed that there is no significant change or shifting in absorption peaks in pure drug + excipient as compared to pure drug. It proves that there is no significant interaction between drug and excipients.

Differential Scanning Calorimetry (DSC):

DSC thermogram of pure drug with polymer were carried out and shown in figure 3 respectively.

Figure 3: FTIR Spectra of Famotidine + SSG + CP + CCS

From the above DSC thermograms it is observed that pure famotidine drug with all polymers gives melting point peak at 166.01 C near about same. Therefore, it is revealed that polymer blend does not show significant shifting in DSC peak due to absence of any interaction with the drug showing good compatibility.

Pre compression evaluation of formulation powder:

The bulk density obtained for all the formulations in the range of 0.45 ± 0.0125 - 0.48 ± 0.0134 g/ml and the tapped density in the range of 0.49 ± 0.0099 - 0.55 ± 0.0218 g/ml The Angle of repose of the powder blend of all the formulations was found in range of 20.3 ±0.3055 - 32.6 ±0.3464 which is in the Excellent or in the good range means showing the excellent flowability necessary for proper flow of powder. The Compressibility index of the powder blend of all the formulations was found in the range of 10 ± 0.00 – 16.36 ±0.00 %. which is accepted range means showing good or fair mixture possess good flow of powder and compressibility properties flowability for proper flow of powder blend. The Hausner's ratio was found to be in the range of 1.11 ± 0.0115 – 1.19 ±0.0057 All these results indicated that the powder.

Figure 4: DSC Thermogram of Drug and Polymers

Post compression evaluation formulation (tablet):

The weight variation obtained for all the formulations in the range of 205.10±1.48 - 207.10±1.61 mg and the diameter in the range of 7.73±0.32 - 7.96±0.20 mm. The thickness of the tablets of all the formulations was found in range of 2.96±0.05 - 3.0±0.11 mm which is in the good range. The hardness of the tablets of all the formulation was found in the range of 3.0±0.12- 3.4±0.10 kg/cm2 which is excellent or in the acceptable range. The friability was found to be in the range 0.8±0.5 -0.9±0.14%. The drug content was obtained in the acceptable limit. The drug content was found in the range 96.70 ± 0.16- 99.0.4 ± 0.05%w/w. (i.e. 99-101% w/w). The found range was within the specified limit as per Indian Pharmacopoeia 2007

Table 3: Pre-Compression Parameters for the Formulations

Formulation Code	Bulk density (g/ml)	Tapped density (g/ml)	Angle of repose (Ө)	Compressibility index%	Hausner's ratio
F1	0.45±0.0125	0.50±0.0231	24.7±0.2645	13.72±0.00	1.15±0.0057
F2	0.44±0.0042	0.49±0.0099	20.3±0.3055	10±0.00	1.11±0.0115
F3	0.45±0.0090	0.50±0.0063	27.02±0.0723	13.46±0.07	1.15±0.0057
F4	0.47±0.0120	0.54±0.0217	28.3±0.2081	12.96±0.12	1.14±0.01
F5	0.45±0.0125	0.50±0.0107	20.8±0.2645	10±0.00	1.11±0.0115
F6	0.48±0.0134	0.55±0.0218	32.6±0.3464	16.36±0.00	1.19±0.0057
F7	0.46±0.0103	0.53±0.0214	24.2±0.4932	13.20±0.12	1.15±0.0057
F8	0.44±0.0043	0.52±0.0213	22.7±0.2081	10.20±0.00	1.11±0.0115

All values are expressed as mean± SE, n=3.

Table 4: Post-Compression Parameters for the Formulations

Formulation code	Weight variation	Diameter (mm)	Thickness (mm)	Hardness (kg/cm²)	Friability (%)	Drug content (%w/w)
F1	204.6±1.18	7.86±0.20	2.90±0.10	3.26±0.05	0.8±0.05	96.70±0.16
F2	205.15±1.59	7.73±0.32	2.9±0.17	3.36±0.11	0.8±0.15	98.52±0.26
F3	206.15±1.63	7.83±0.24	2.76±0.25	3.26±0.15	0.9±0.14	97.74±0.14
F4	207.10±1.61	7.96±0.20	2.80±0.10	3.36±0.15	0.9±0.13	98.78±0.25
F5	201.55±1.63	7.83±0.20	2.8±0.10	3.0±0.10	0.9±0.11	99.04±0.05
F6	205.10±1.48	7.80±0.45	3.0±0.10	3.4±0.10	0.8±0.09	97.48±0.16
F7	206.40±1.66	7.93±0.35	2.86±0.11	3.4±0.10	0.8±0.06	98.26±0.26
F8	207.15±1.53	7.76±0.30	2.96±0.05	3.4±0.10	0.9±0.10	98.78±0.25

All values are expressed as mean± SE, n=3.

Disintegration time:

Tablets were subjected for the in-vitro disintegrate time in the USP Disintegrate test apparatus. (Veego scientific VTD-DV) The in-vitro disintegrate time for all eight formulations varied from 12±1.8973 to 30±1.8973 seconds. The rapid disintegrate was seen in the formulations containing Crospovidone and Croscarmellose sodium. This is due to rapid intake of the water from the medium, swelling and burst effect. It also noticed that the concentration of Croscarmellose sodium followed by Crospovidone and Sodium starch glycollate increased, the time taken for the disintegrate was reduced Wetting time and water absorption ratio The wetting time for all eight formulations was performed in duplicate. The values between 11±1.4142 to 42±1.8973 seconds.

The wetting time was rapid in Crosscarmellose sodium followed by Crosspovidone and Sodium starch glycollate. Here also it was observed that as the concentration of disintegrant increased the time taken for wetting was reduced. Water absorption ratio which is important criteria for understanding the capacity of disintegrants to swell in presence of little amount of water was calculated. It was found in the range of 78.45 ±5.92 to 125.80±5.10%. (Table 5) Water absorption ratio (R) increases with the increased concentration of Croscarmellose sodium followed by crosspovidone and sodium starch glycollate. Hence highest water absorption 125.80% of F5.

Table 5: Post-Compression Parameters for the Formulations

Formulation code	Disintegration time (sec)	Wetting time (sec)	Water absorption ratio (%)
F1	20±2.000	25±3.2863	81.26±0.983
F2	15±1.4142	20±2.0000	90.28±3.982
F3	30±1.8973	17±1.4142	112.40±1.88
F4	19±1.4142	42±1.8973	78.45±5.92
F5	12±1.8973	11±1.4142	125.80±5.10
F6	25±3.2863	23±2.2803	96.66±1.41
F7	15±1.4142	26±2.0000	84.24±6.02
F8	22±1.4142	17±1.4142	96.66±5.40

All values are expressed as mean± SE, n=3

In Vitro Dissolution Study:

Drug release study was further carried out in phosphate buffer PH6.8. The F8 formulation. Percent cumulative drug release for all formulations was found in the range of 88.27±0.5352 to 99.24±0.1401% drug release was increased with the increasing concentration of super disintegrants. F5 formulations showed highest drug release i.e., 99.24% in almost first 15 minutes.

Table 6: Percentage of Drug Release of Famotidine Formulations ODTs.

Time (min)

Formulation code (Drug Release %)

0.00

70.25±

1.0727

76.9±

1.2227

70.45±

1.1015

83.7±

0.0305

85.5±

0.1228

72.45±

0.1285

76.55±

0.3821

72.25±

1.1149

72.49±

0.1285

83.72±

0.0305

76.44±

1.3030

85.46±

0.1228

90.07±

0.1216

78.75±

1.1832

81.12±

1.4953

80.95±

1.2989

77.15±

1.1832

86.31±

0.8357

87.87±

0.6992

89.92±

1.3308

93.45±

0.2523

83.76±

0.2663

84.45±

1.0001

83.28±

0.5881

85.27±

0.5538

90.29±

0.1216

88.93±

0.8304

93.74±

0.1450

97.41±

1.1328

87.61±

0.2165

89.91±

1.2189

87.44±

0.4384

88.27±

0.5352

94.26±

0.4079

90.09±

0.7794

96.14±

1.1714

99.24±

0.1401

91.43±

2.0351

93.94±

1.9813

93.59±

0.2523

All values are expressed as mean± SE, n=3.

Figure 4: Cumulative % drug release profile of formulation F1-F8.

Analysis of Data:

To investigate the influence of 3 factors, full factorial design was used; polynomial equation was deduced to study the impact of independent variables upon the responses i.e., % drug release and disintegration time. Inference on results is obtained by regression equations after considering the magnitude of the coefficient and the sign of coefficient indicates the type of response. Positive sign in the polynomial equation infers that the response increases with increase in the value and negative sign shows the decrease in response with increase in the value. The kind of response when two factors were changed simultaneously is given by interaction terms.

Effect of independent factors on % drug release (Y1)

Drug release=+93.31+1.82*A+1.42* B+1.96* C-0.21*A* B-0.34*A* C+1.00* B * C+0.28*A*B*C.

Based on this polynomial equation, it was observed that the independent variables viz. Croscarmellose sodium, SSG and Crospovidone had a positive effect on drug release

3D Response Surface Plot:

§ Effect of Croscarmellose Sodium, SSG and Crospovidone on drug release Time of Famotidine in 3D response surface plot confirmed. From the figure response curve of Y1 (Drug release),

§ It is observed that as concentration of Croscarmellose sodium increases from 4 mg to 8 mg, SSG increases from 4 mg to 8 mg and Crospovidone increases from 4 mg to 8 mg drug release increases significantly.

Effect of independent factors on disintegration time (Y2)

Disintegration time =+19.75-3.75* A-0.75* B-2.00*C-1.75*A* B-0.50*A*C-1.50*B* C+2.50 * A*B*C.

Based on this polynomial equation, It was observed that the independent variables viz. Croscarmellose sodium, SSG and Crospovidone had a negative effect on Disintegration time.

3D Response Surface Plot

· Curve of Y2 (Disintegration Time), it is observed that as concentration of Croscarmellose sodium increases from 4 mg to 8 mg, SSG increases from 4 mg to 8 mg and Crospovidone increases from 4 mg to 8 mg Disintegration Time decreases significantly as shown in fig.

· Statistical model shows run number 8 as an optimized formulation.

· The study of response i.e., drug release - 99.24% % and Disintegration Time - 12 Sec of optimized batch.

Stability Studies

Studies for optimized formulation F5 of ODTs Famotidine tablet at 40°C ± 2°C /75% RH ± 5%

Table 7: Stability study of optimized formulation

Sr. No	Observation	Before Stability	15 Days	1 Month
1	Appearance	White	White	White
2	Disintegration Time (sec)	12 ± 1.8973	11.80 ± 1.632	11.65 ± 0.632
3	Dissolution Time	99.24 ± 0.1401	99.20 ± 0.1311	98.52 ± 0.041
4	Drug Content	99.04 ± 0.032	99.02 ± 0.011	98.95± 0.080

From the above observations it was found that there is no significant changes in disintegrate time, release characteristics and physicochemical properties of the tablets.

CONCLUSION:

Orodispersible tablet of Famotidine were prepared and optimized using 2³ full factorial design. The concentration of sodium starch glycolate, Croscarmellose sodium and crospovidone were selected as three independent variables which is dependent parameters, and drug release, disintegration time. Design expert 8.0.7.1 was used to optimize and to draw respective polynomial equations, response surface plots. The optimized formulation exhibited a disintegration time of 12 sec. and drug release of 99.24% within 15 min which were closed to predicted values confirmed the validity of the design. The compatibility and stability of optimized formulation were proved.

REFERENCES:

1. Abhay Asthana, Swati Aggarwal, Gayti Asthana. Oral Dispersible Tablets: Novel Technology and Development, International Journal of Pharmaceutical Sciences Review and Research. 2013; 20(1): 193-199.

2. K.P.R. Chowdary, K. Ravi Shankar and B. Suchitra. Recent Research on Orodispersible Tablets – A Review. International Research Journal of Pharmaceutical and Applied Sciences. 2014; 4(1): 64-73.

3. Leon Lachman, Herber. A. Lieberman: Theory and Practice of Industrial Pharmacy. Varghese Publishing House, III rd. edition. 293

4. Herbert A. Lieberman, Leon Lachman, and Joseph B. Schwartz: Pharmaceutical Dosage Forms: Tablets. IInd edition, Volume III rd. 1-74

5. Raymond C., Rowe, Paul J., Sheskey and Sian C., Owen., Hand Book of Pharmaceutical Excipients, 4th edn., Pharmaceutical Press, London, 2003.

6. Vyomesh N. Raval, Gajanan J. Deshmukh, A. K. Seth. Oro Dispersible Tablets. Indo American Journal of Pharmaceutical Research Research. 2011: 1: 42-50

7. Lieberman HA, Lachman L. Pharmaceutical dosage forms tablets. 2nd ed. New York: Marcel Dekker. 1989; 198: 9-15

8. United States Pharmacopeia. National Formulary USP/NF18. Peckville M.D., New York: The United States Pharmacopeia Convention. 1995; 15: 133-145

9. Banker GS, Anderson NR. In: Lachman L, Lieberman HA, Kanig JL, Eds. The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Varghese Publishing House. 1987; 293-399.

10. Arora P, Arora V. Orodispersible tablets: A comprehensive review. Int. J. Pharm. Sci. Res. 2013; 2(2): 270-281.

11. Furtado S. Development and Characterization of Orodispersible Tablets of Famotidine Containing a Subliming Agent. Tropical Journal of Pharmaceutical Research. 2008; 7(4): 1185-1189.

12. British Pharmacopoeia: Famotidine. Volume I and II. 2013. Ph. Eur. Monograph 1012.

Received on 06.06.2024 Revised on 13.07.2024

Accepted on 07.08.2024 Published on 18.11.2024

Available online from December 19, 2024

Res. J. Pharma. Dosage Forms and Tech. 2024; 16(4):317-324.

DOI: 10.52711/0975-4377.2024.00049