1. INTRODUCTION:

The most common and favoured route of drug administration is through the oral route. Fast dissolving tablets are gaining position among novel oral drug-delivery system as they have improved patient compliance and have some added advantages compared to other oral formulations.

They are solid unit dosage forms, which disintegrate in the mouth within a minute in the presence of saliva due to super disintegrants in the formulation^1,2. It provides numerous advantages with respect to its stability, administration without water, accurate dosing, easy manufacturing, small packaging size, and handling. Its ease of administration in the population especially for paediatrics, geriatrics or any mentally retarded persons makes it a very widespread dosage form. Because of the presence of super disintegrants, it gets dissolved rapidly, ensuing rapid absorption of drug which in turn provides rapid onset of action. As the absorption is taking place directly from the mouth, bioavailability of the drug increases³.

Various superdisintegrants such as Croscarmellose sodium, crosspovidone and sodium starch glycolate are used in formulating mouth-disintegrating tablets. These are used alone or in combination with another in several concentrations. Diverse absorption sites for drug in saliva would be mouth, pharynx, oesophagus and stomach⁴. It depends on how quickly drug comes into solution and how quickly it is absorbed. Co-processed excipients have been developed to handle changes in the physical properties of particles at sub-particle levels^5,6. By co-processing two excipients, formulators can produce an excipient with superior properties as compared to the individual ingredients⁷.

Losartan is used to treat hypertension and also used to lower the risk of stroke in certain people with heart disease. Losartan belongs to a group of drugs called angiotensin II receptor antagonists. It keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. It undergoes first pass metabolism due do which it has low bioavailability of 33%.

Fast onset of action is major concern in the management of hypertension. Therefore, in the present study, attempts were made to formulate mouth dissolving tablets of losartan potassium using coprocessed superdisintegrants in order to improve the dissolution rate which thereby increase the bioavailability, to achieve fast onset of action and increase patient compliance.

2. MATERIALS:

Losartan potassium was received as a gift sample from Dr. Reddy’s Labs, Hyderabad. All other chemicals like micro crystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate, talc, potassium dihydrogen phosphate and sodium hydroxide purchased were of analytical grade.

3. PREFORMULATION STUDY:

Preformulation is group of studies that focus on the physicochemical properties of a new drug candidate that could affect the drug performance and the development of a dosage form⁸.

a) Organoleptic Properties:

Pure drug was evaluated for organoleptic properties such as appearance and colour.

b) Solubility Analysis:

The solubility of Losartan Potassium was checked in water and organic solvents. The solubility was analysed by quantitative determination using UV spectroscopy at a wave length of 251nm.

c) Melting Point Determination:

Melting point determination of pure drug Losartan Potassium was done by capillary tube method.

d) Identification of Pure Drug:

FTIR spectroscopy was used for identification of pure drug Losartan Potassium.

e) Determination of Absorption maximum (λ max):

20µg/ml concentration of Losartan Potassium solution was prepared by using phosphate buffer of pH 6.8. The solution was then scanned in UV-Visible spectrophotometer from 200 - 400nm to determine the λ_max.

f) Calibration curve:

Preparation of Primary Stock Solution:

An accurately weighed amount of 10mg Losartan potassium was transferred into a 100ml volumetric flask and dissolved in small amounts of pH 6.8 phosphate buffer. The final volume is made up with pH 6.8 phosphate buffer to get a concentration of 100µg/ml.

Preparation of working standard solutions:

From the above stock solution 2, 4, 6, 8 and 10ml of stock solution were pipetted out into 100ml volumetric flasks. The volumes were prepared up to the mark with pH 6.8 phosphate buffer. These dilutions gave 2, 4, 6, 8 and 10µg/ml concentration of Losartan potassium. The absorbance of each standard solution was measured by using UV-Spectrophotometer at 251nm. The calibration graph was plotted by using concentration on X axis and absorbance on Y axis.

g) Drug Excipients Compatibility study:

Drug excipient compatibility study was performed by potassium bromide pellet method using Fourier transform infrared spectrophotometer.

4. METHODOLOGY:

Preparation of co-processed Superdisintegrants:

Solvent evaporation method:

A blend of Croscarmellose Sodium and Sodium Starch Glycolate (in the ratio of 1:1, 1:2 and 1:3) was added to 10ml of ethanol. The contents of the beaker (250ml capacity) were mixed thoroughly and stirring was continued till most of ethanol evaporated. The wet coherent mass was granulated through # 60 mesh sieve. The wet granules were dried in a hot air oven at 60°C for 20 minutes. The dried granules were sifted through # 60 mesh sieve and stored in airtight container till further use⁹.

Formulation of Losartan potassium tablets:

Tablets containing 50mg of drug were prepared by direct compression method. Drug was passed through sieve no 100. Drug along with other excipients were mixed in a mortar. The resulting blend was lubricated with magnesium stearate and compressed into tablets using the Karnavathi multiple punch (round shaped, 8mm thick) compression machine.

Table No - 1: Composition of fast dissolving tablets formulated with CCS

S. No	Ingredients (mg)	F1	F2	F3
1	Drug	50	50	50
2	MCC	94	91	85
3	CCS	3 (2%)	6 (4%)	12 (8%)
4	Talc	1.5	1.5	1.5
5	Magnesium stearate	1.5	1.5	1.5
Total Weight		150	150	150

Table No - 2: Composition of fast dissolving tablets formulated with SSG

S. No	Ingredients (mg)	F4	F5	F6
1	Drug	50	50	50
2	MCC	94	91	85
3	SSG	3 (2%)	6 (4%)	12 (8%)
4	Talc	1.5	1.5	1.5
5	Magnesium stearate	1.5	1.5	1.5
Total Weight		150	150	150

Table No - 3: Composition of fast dissolving tablets formulated with coprocessed superdisintegrants (CCS: SSG)

S. No	Ingredients (mg)	F7(1:1)	F8(1:2)	F9(1:3)
1	Drug	50	50	50
2	MCC	85	85	85
3	CCS: SSG	12	12	12
4	Talc	1.5	1.5	1.5
5	Magnesium stearate	1.5	1.5	1.5
Total Weight		150	150	150

Precompression parameters:

Before the compression the prepared blend was evaluated for subsequent parameters.

(a) Bulk Density:

The bulk density was determined by using bulk density apparatus. Apparent bulk density was obtained by pouring 5g of powder into a 100ml graduated cylinder. The bulk volume and powder weight were determined¹⁰. The bulk density was calculated by following formula.

Bulk Density = Weight of powder / Bulk Volume

(b) Tapped Density:

After the known mass (5 g) of powder was poured into the measuring cylinder, it was tapped for 100 times. Then the minimum volume occupied in the cylinder was measured¹¹. The tapped density was calculated by following formula.

Tapped Density = Mass of the powder / Tapped volume of powder.

(c) Carr’s index:

The Carr’s index is an indication of the compressibility of a powder. It is calculated by using the formula.

Carr’s index = (Tapped Density - Bulk Density / Tapped Density) × 100

(d) Hausner’s Ratio:

It is the ratio of tapped density and bulk density¹². It was calculated by using the following formula.

Hausner’s ratio = Tapped density / Bulk density

(e) Angle of repose:

The angle of repose of the powder blend was determined by fixed funnel method¹³. Angle of repose (θ) was calculated by using the following formula.

Angle of repose θ = Tan^-1(height of the cone /radius of the cone)

Post Formulation Studies:

(a) Weight variation:

According to I.P twenty tablets were taken and their weight was determined individually with the use of digital weighing balance. The average weight of the single tablet was determined from the overall collective weight¹⁴.

(b) Thickness:

The thickness of the tablets was measured by using vernier callipers.

(c) Hardness:

The hardness of tablet was determined by using Pfizer hardness tester. It is defined as force required breaking a tablet by Compression in a radial direction. An average of three observations was reported.

(d) Disintegration time:

The process of breaking of tablet into smaller particles is referred as disintegration. One tablet was placed in each of the 6 tubes of the basket and apparatus was operated using phosphate buffer maintained at 37^°C±2°C. Then the basket was moved up and down through a distance of 5 – 6cm at a frequency of 28 to 32 cycles per minute. The time taken for complete disintegration of the tablet with no sign of palpable mass remaining in the apparatus was measured and recorded¹⁵.

(e) Friability Test:

Friability of the tablets was determined using Roche friabilator. Before placing the tablets in the apparatus, the initial weight of the tablets was noted. The plastic chamber is revolved at 25rpm for 4 minutes and tablets were subjected to abrasion¹⁶. Then the tablets were de dusted and reweighed. The % friability can be calculated by using the following formula.

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

(f) Drug Content:

In this test, the tablets were weighed and powdered. An accurate amount of powder equivalent to 50mg of Losartan potassium was dissolved in a 100ml of pH 6.8 phosphate buffer which is filtered and diluted and analysed for drug content at 251nm using UV-Visible Spectrophotometer. From the obtained absorbance values, amount of drug present in the given tablet was calculated^17,18.

(g) Wetting time:

In this test five circular tissue papers of 10cm diameter were placed in a Petri dish. 10ml of Eosin, a water-soluble dye is added to the Petri dish and kept aside for few minutes. Then the tablet was gently placed on the surface of tissue paper¹⁹. The time required to develop a red colour on the upper surface of the tablet was recorded as the wetting time.

(h) In vitro Dissolution Study:

In vitro release study of Losartan potassium tablets was studied by using dissolution testing apparatus USP Type II (paddle), with the rotation speed of 50rpm using pH 6.8 phosphate buffer as dissolution medium maintained at a temperature of 37±0.5^°C. Samples were withdrawn at regular intervals and filtered through whatman filter paper, diluted and analysed at 251 nm for cumulative amount of drug release using double beam UV-Visible spectrophotometer^20,21.

(i) Accelerated Stability Study of Optimized Batch:

The optimized formulation F7 was stored in aluminum capped clear glass vials and were subjected to a storage condition of 40°C±2˚C/ 75%±5% RH for 3 months in humidity chamber. The samples were withdrawn at time intervals of 0, 1, 2 and 3 months and evaluated for hardness, friability, disintegration time, drug content and in-vitro dissolution studies²².

5. RESULTS AND DISCUSSION:

PREFORMULATION STUDIES:

Organoleptic Properties:

The pure drug Losartan Potassium showed white to off-white free-flowing crystalline powder.

Solubility Studies:

Losartan potassium was found to be freely soluble in water; soluble in alcohols; slightly soluble in common organic solvents, such as acetonitrile, methyl ethyl ketone. The solubility in water was found to be 1.23 mg/ml.

Melting Point Determination:

After performing capillary method melting point of Losartan Potassium was found to be 268°C.

Identification of Pure Drug:

FT-IR spectroscopy was used to determine the functional group present in the pure drug sample.

Drug Excipient Compatibility Study:

The interaction studies were performed to find any kind of interaction between drug and excipients used in the fast-dissolving tablets. FT-IR spectroscopy was used to determine the functional group present in the pure drug sample^23,24.

Inference:

The report of FTIR studies suggested that there was no drug excipient interaction. The FTIR spectrum of drug with excipients showed the retention of these characteristic peaks of Losartan potassium revealing no interaction between the selected drug and excipients. This indicates that the drug is stable and there is no drug-excipient interaction.

METHODOLOGY:

Preparation of Coprocessed Superdisintegrants:

A blend of coprocessed superdisintegrant with different ratio of Croscarmellose Sodium and Sodium Starch Glycolate (1:1, 1:2 and 1:3) was prepared by solvent evaporation method.

Formulation of Losartan Potassium tablets:

Tablets containing 50mg of Losartan Potassium were prepared by direct compression method. Nine different formulations of FDTs were prepared with different concentration of Croscarmellose sodium, Sodium Starch Glycolate and its combination as coprocessed superdisintegrants. To know the influence of concentration of the Croscarmellose sodium on the performance of Losartan Potassium, a set of three formulations (F1, F2, F3) were prepared using three different concentrations of Croscarmellose sodium (2%, 4% and 8% w/w) respectively. To know the impact of concentration of the Sodium Starch Glycolate on the performance of Losartan Potassium, a set of three formulations (F4, F5 and F6) were formulated using three different concentrations of Sodium Starch Glycolate (2%, 4% and 8% w/w) respectively. To identify the influence of co-processed superdisintegrants on performance of Losartan Potassium, a set of three formulations (F7, F8 and F9) were prepared using co-processed superdisintegrants (CCS: SSG) in three different ratios 1:1, 1:2 and 1:3 respectively. The formulated tablets were subjected to various quality control tests and all the tablets complied with the Pharmacopoeial standards.

Precompression Parameters:

Bulk density and Tapped density:

The powdered blends of all nine formulations were evaluated for bulk density and tapped density by using bulk density apparatus and the results were shown in Table No - 5. The bulk density was found in the range of 0.337±0.02 to 0.552±0.03gm/cm³. The tapped density ranged from 0.394±0.03 to 0.622±0.05gm/cm³. This indicates that powder is loosely packed. These values were further used for calculating Carr’s index and Hausner’s ratio to check the flowability of powder.

Table No - 5: Bulk density and Tapped density of all the formulations F1-F9

S. No	Formulation code	Bulk density (gm/cm³⁾	Tapped density (gm/cm³)
1	F1	0.527±0.02	0.591±0.03
2	F2	0.457±0.03	0.484±0.45
3	F3	0.337±0.02	0.394±0.03
4	F4	0.421±0.12	0.461±0.06
5	F5	0.372±0.06	0.444±0.08
6	F6	0.481±0.05	0.521±0.07
7	F7	0.396±0.03	0.421±0.04
8	F8	0.552±0.03	0.622±0.05
9	F9	0.532±0.06	0.609±0.08

Mean ± S.D of three determinations

Table No - 6: Carr’s Index and Hausner’s ratio

S. No	Formulations	Carr’s index	Hausner’s ratio
1	F1	10.83±0.65	1.12±0.041
2	F2	5.58±0.5	1.06±0.54
3	F3	14.47±0.26	1.17±0.24
4	F4	8.68±0.20	1.10±0.19
5	F5	16.22±0.11	1.19±0.04
6	F6	7.68±0.62	1.08±0.06
7	F7	5.94±0.45	1.06±0.03
8	F8	11.25±0.3	1.13±0.27
9	F9	12.64±0.23	1.14±0.52

Mean ± S.D. of three determinations

Carr’s Index and Hausner’s ratio:

The compressibility index and Hausner’s ratio values of all the nine formulations indicate that the prepared blends possessed minimum interparticulate interactions and good flow property which is preliminary requirement for formulating the tablets.

Table No - 7: Angle of Repose

S. No	Formulation code	Angle of repose
1	F1	25.6±0.31
2	F2	26.2±0.41
3	F3	25.2±0.44
4	F4	26.6±0.55
5	F5	25.1±0.98
6	F6	27.1±0.51
7	F7	26.4±0.16
8	F8	25.2±0.80
9	F9	27.5±0.53

Mean ± S.D. of three determinations

Angle of repose:

The prepared powder blends of all the formulations were evaluated for the flow properties. The angle of repose of all formulations was within the range of 25.1^o - 27.5^o. These values indicate that the powder blend F1 – F9 had exhibited good flow properties.

Post Compression Parameters:

All the formulations were prepared under similar conditions and tablets exhibited white colour, convex in shape with smooth surface. The characteristics of prepared tablets of Losartan Potassium are discussed below.

The hardness for the tablets of all formulations was adjusted to 3.1 to 3.4 Kg/cm² so that the effect of superdisintegrant on the dissolution rate could be evaluated accurately. The friability of all the formulated tablets was within 1%, which is an indication of good mechanical resistance of the tablet. The drug content varied between 97.30%±0.32 to 99.52%±0.27 for all formulations. The thickness was measured for the tablets of all formulations and was found to be within the acceptable range. The percentage variation in weight was within the range of ±7.5% complying with pharmacopoeial specification.

Wetting Time:

Wetting time was given the major importance in selection of the best fast dissolving tablet formulation among all the 9 formulations. For all the formulations, with increase in the superdisintegrant concentration from 2 to 8%, the wetting time decreased accordingly. It is clear from the results that the formulation containing SSG had shown more wetting time than CCS and its combination.

This may be due to the fact that SSG is disintegrated by swelling mechanism leading to longer wetting time and lesser water absorption ratio. The formulations that contain CCS have the shortest wetting time, which may be attributed to the strong wicking action of this super disintegrant. The wetting time was in the range of 17.47 seconds to 79.55 seconds. The result shows that all the formulations pass the test and the formulation F7 showed minimum wetting time of 17.47 seconds.

Table No - 9: Wetting time of Losartan Potassium FDTs

S. No	Formulation code	Wetting time (sec)
1	F1	63.31±0.36
2	F2	38.39±0.47
3	F3	27.29±0.73
4	F4	79.55±0.24
5	F5	65.19±0.45
6	F6	43.29±0.97
7	F7	17.47±0.52
8	F8	24.31±1.02
9	F9	38.01±1.42

Mean ± S.D. of three determinations

Disintegration Time:

Disintegration time is very important for fast dissolving tablets which are desired to be less than 60 seconds. This rapid disintegration plays a role in drug absorption in buccal cavity, which promotes the bioavailability of the drug. The in vitro disintegration time of prepared tablets (F1 – F9) was present between 27 to 161 seconds respectively. Out of all the formulations, F7 tablets prepared using 1:1 ratio of CCS: SSG showed rapid disintegration in 27 sec. It was clear that the disintegration time of CCS containing tablets were comparatively lower than tablets containing SSG. This may be due to its rapid capillary activity and pronounced hydration with little tendency to form gel when comes in contact with buffer and water.

Table No - 10: In-vitro Drug disintegration time

S. No	Formulation Code	*In-vitro* disintegration time (Sec)
1	F1	126±0.01
2	F2	104±0.23
3	F3	51±0.34
4	F4	161±0.26
5	F5	118±0.18
6	F6	79±0.26
7	F7	27±0.46
8	F8	40±0.56
9	F9	54±0.42

Mean ± S.D. of three determinations

In-vitro Release Study:

The release profiles of the formulations were determined using USP dissolution apparatus Type II at 37.0±0.5^°C. The FDTs were placed in dissolution flask containing pH 6.8 PBS solution. Then the paddle was rotated at 50rpm, and immediately aliquots of 5ml sample were withdrawn at every two minutes over a period of 12 minutes. The drug content was determined at 251nm by using UV spectrophotometer.

The in vitro drug release studies were performed to evaluate the release of FDTs. The cumulative percentage release in pH 6.8 PBS for all the formulations was recorded and the formulation F3, F6 and F7 showed higher drug release i.e., 93.01%, 83.42% and 98.80% respectively within 12 minutes. The higher drug release from these formulations was possible due to presence of higher concentration of the super disintegrant. The cumulative amounts of drug released from the formulations are shown in Table No – 11.

The drug release of nine formulations were compared with each other and the results are represented diagrammatically and it was shown in figure numbers 5 to 8. The tablets formulated with 8% CCS (F3) showed greater rate of dissolution when compared to the tablets formulated with SSG. In formulation F7 containing 1:1 ratio of CCS: SSG showed better dissolution rate than those of all other formulations. This might be because of its high disintegrating nature.

The formulation prepared with 8% w/w of superdisintegrant offered relatively rapid release of Losartan potassium when compared with other concentrations of Croscarmellose sodium and Sodium Starch Glycolate. The formulation prepared with Croscarmellose sodium offered relatively rapid release of Losartan potassium when compared with Sodium Starch Glycolate. Formulation containing Co-processed mixtures had less disintegration time as compared to the individual superdisintegrants. Hence the nature, concentration of the superdisintegrant and combination of superdisintegrants (Co-processed) showed influence on the rate of dissolution.

Figure No - 5: Comparative Dissolution Profiles of Formulations F1 to F3

Figure No - 6: Comparative Dissolution Profiles of Formulations F4 to F6

Figure No - 7: Comparative Dissolution Profiles of Formulations F7 to F9

Figure No - 8: Comparison of Dissolution Profiles of Formulations F3, F6 & F7

Stability Study:

The stability study was conducted on the selected formulation F7 as per the ICH guidelines. The stability studies were done at the intervals of 0, 30, 60 and 90 days. The parameters studied were disintegration, hardness, friability, percentage drug content and percentage of drug release. The results are shown in Table No - 12. From the results it was concluded that there were no significant changes in any values. Hence this formulation was considered to be stable after three months stability study.

Table No - 12: Stability Studies of Formulation F7

Parameter	Time (days)
	0	30	60	90
Disintegration Time in seconds	27±0.46	28 ± 0.34	27 ± 0.56	28 ± 0.42
Hardness (Kg/Cm²)	3.3±0.15	3.2 ± 0.51	3.1 ± 0.42	3.1 ± 0.42
Friability (%)	0.34± 0.023	0.35 ± 0.004	0.38 ± 0.050	0.36 ± 0.012
Drug content (%)	99.52± 0.27	99.23%± 0.79	98.26%± 0.23	98.12%± 0.34
Drug release (%)	98.80± 0.37	98.23± 0.69	97.95± 0.32	97.85± 0.25

6. CONCLUSION:

In the present research work, to study the influence of pharmaceutical excipients on performance of Losartan Potassium, two superdisintegrants and its combination of at different concentrations were used to prepare fast dissolving tablets. An increased superdisintegrant associated with enhanced wicking, disintegration and thus, enhanced drug release. Formulation containing Co-processed mixtures had less disintegration time and rapid drug release as compared to the individual superdisintegrants. Therefore, the nature, concentration of the superdisintegrant and combination of superdisintegrants (Co-processed) showed influence on the rate of dissolution. The optimized formulation F7 revealed a percentage cumulative drug release (CDR) of 98.80% at the end of 12 minutes. Thus, the objective of Losartan Potassium with co-processed superdisintegrants to achieve faster dissolution rates was met with success.

7. ACKNOWLEDGEMENT:

The authors sincerely thank Vijaya Institute of Pharmaceutical Sciences for Women, Vijayawada for providing necessary equipments and their support in the fulfilment of the research work successfully.

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Received on 19.04.2022 Modified on 14.09.2022

Asian J. Pharm. Tech. 2023; 13(1):9-18.

DOI: 10.52711/2231-5713.2023.00003

S. No	Concentration (µg/ml)	Absorbance in pH 6.8 PBS
1	0	0.000
2	2	0.245
3	4	0.385
4	6	0.554
5	8	0.721
6	10	0.891

Formulation Code	Hardness (kg/cm²)	Friability (%)	Weight variation (%)	Thickness (mm)	Drug content (%)
F1	3.1±0.24	0.239±0.020	2.4±0.48	3.1±0.007	97.89±0.05
F2	3.2±0.22	0.423±0.002	3.5±0.63	3.2±0.002	97.62±0.26
F3	3.3±0.17	0.220±0.005	3.2±0.13	3.1±0.004	97.89±0.25
F4	3.2±0.15	0.534±0.011	2.3±0.32	3.0±0.003	98.94±0.23
F5	3.4±0.22	0.612±0.004	2.7±0.23	3.1±0.001	97.45±0.43
F6	3.2±0.23	0.426±0.013	3.1±0.31	3.0±0.007	98.63±0.26
F7	3.3±0.15	0.336±0.023	2.4±0.13	3.2±0.005	99.52±0.27
F8	3.4±0.17	0.535±0.002	2.8±0.63	3.1±0.003	97.30±0.32
F9	3.2±0.16	0.544±0.005	3.7±0.16	3.2±0.002	98.62±0.34