Advancements in Pharmaceutical Formulations:

Formulation and Evaluation of Taste-Masked Suspension of Mefenamic Acid

Vikram S. Gharge, Krishna B. Kinage, Anup A. Kulkarni, Rohit S. Kharade

¹Zuventus Healthcare Limited Plot No. P-2, SBM, Ground Floor (Part-b) and First Floor.

I.T.B.T. Park, Phase –II, Midc Hinjawadi, Pune – 411057.

*Corresponding Author E-mail: vikram.gharge@zuventus.com

ABSTRACT:

The present article describes formulation and evaluation of Mefenamic acid suspension. Mefenamic acid is BCS class II drugs i.e. low solubility and high permeability. Mefenamic acid suspension was formulated for pediatric patient. Major challenge is to mask a bitter taste of Mefenamic acid. The taste masking of Mefenamic acid is achieved by the matrix-based technology in drug adsorbed or entrapped in the matrix of the porous component. This may result in a delayed release of the bitter active during the transit through the oral cavity. Mefenamic acid suspensions were formulated using different concentration of Xanthan gum, Carbopol 934 P and Veegum K. The Sucrose and artificial sweetener were added to mask a bitter taste. The trials of Mefenamic acid suspension were evaluated for different parameters like macroscopy, pH, viscosity, taste evaluation, In-vitro drug release and assay. Based on the result, F 6 batch was selected for further study. The F 6 batch gives optimum viscosity, No sedimentation and phase separation. The percentage of drug release was found 100.99% at 60 minutes. The F6 formulation is sweet in taste with pleasant odour. So, based on the physical and chemical parameter of taste masked F6 formulation of mefenamic acid gives promising career for pediatric delivery.

KEYWORDS: Mefenamic Acid, Suspension, Taste Masking, Oral delivery, NSAIDs

INTRODUCTION:

Children frequently have difficulty following medication regimens because of the unpleasant taste of some drugs, which can lead to deteriorating health conditions if not properly managed. To address this issue and enhance patient adherence, several taste-masking technologies have been developed^1-3. While sweeteners, flavorings, and amino acids can be somewhat effective, they often fall short when it comes to masking the strong bitterness of very unpalatable drugs.

More advanced techniques—such as polymer coating, microencapsulation, ion exchange resins, inclusion complexes, granulation, adsorption, and the prodrug approach—have demonstrated greater success in masking the taste of particularly bitter medications^3-6.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used medications. Mefenamic acid, a potent NSAID, is employed for its anti-inflammatory, antipyretic, and analgesic effects. Classified as a BCS class II drug, Mefenamic acid's bioavailability is significantly affected by its dissolution rate^7-12. It works by inhibiting the synthesis of prostaglandins, which are essential for maintaining physiological balance. Around 40% of newly discovered drugs are lipophilic and encounter challenges in reaching the market due to poor water solubility. Improving solubility and dissolution rates is crucial for enhancing the bioavailability of BCS class II drugs.

To address these solubility and dissolution issues, various pharmaceutical technologies are being explored, including micronization, nano-suspension, supercritical fluid processes, solid dispersions, solid solutions, sonocrystallization, co-solvency, and hydrotropy. Mefenamic acid is available in tablet, capsule, and pediatric suspension forms. However, its low solubility, hydrophobic nature, and tendency to adhere to surfaces complicate granulation, tableting, and dissolution processes. A suspension is defined as a coarse dispersion where solid particles of a specific size range are evenly distributed throughout a liquid phase, often with the assistance of suspending agents.

MATERIALS AND METHODS:

Materials:

Mefenamic acid (Active Pharmaceutical Ingredient) and all other excipient such as Xanthan gums, Carbopol 974 P, Veegum K (Aluminium Magnesium Silicate) surfactant Sucrose laurate was obtained from Zuventus Healthcare Limited.

Drug excipient Compatibility studies:

In order to check the possible drug excipient interaction, Compatibility studies were performed. The drug Mefenamic acid was mixed with excipient in different ratio and filled in the vials. Initial physical observation checked and the filled vials were charged at stability condition 25°C/60% RH and 40°C/75% RH. The physical observation was checked after 15 days and vials were tested for related substance (Table no.1).

Table no.1

Sr. No.	API: Excipients Details	25°C/60%RH		40°C/75%RH
Sr. No.	API: Excipients Details	API (mg)	Excipients(mg)	API (mg)	Excipients(mg)
1	API	100	NA	100	NA
2	API: Sucrose	100	50	100	50
3	API: Sodium Lauryl Sulphate	100	25	100	25
4	API: Xanthan Gum	100	25	100	25
5	API: Sodium Benzoate	100	25	100	25
6	API: Colloidal Silicon Dioxide	100	25	100	25
7	API: Saccharin Sodium	100	25	100	25
8	API: Color Sunset Yellow FCF	100	25	100	25
9	API: Citric Acid Monohydrate	100	25	100	25
10	API: Simethicone Emulsion 30%	100	25	100	25
11	API: Flavor Mango RSV	100	25	100	25
12	API: Purified Water	100	50	100	50

Initial Physical Observation
Sr. No.	API: Excipients Details	25°C/60%RH	40°C/75%RH
1	API	White powder	White powder
2	API: Sucrose	White crystalline powder	White crystalline powder
3	API: Sodium Lauryl Sulphate	White powder	White powder
4	API: Xanthan Gum	White to off white powder	White to off white powder
5	API: Sodium Benzoate	White powder	White powder
6	API: Colloidal Silicon Dioxide	White powder	White powder
7	API: Saccharin Sodium	White crystalline powder	White crystalline powder
8	API: Colour Sunset Yellow FCF	Orange colour powder	Orange colour powder
9	API: Citric Acid Monohydrate	White crystalline powder	White crystalline powder
10	API: Simethicone Emulsion 30%	Wet mass	Wet mass
11	API: Flavour Mango RSV	Wet mass	Wet mass
12	API: Purified Water	Wet mass	Wet mass

The physical observation after 15 days was summarized in Table no.3.

Table no.3

Physical Observation after 15 days
Sr. No.	API: Excipients Details	25°C/60%RH	40°C/75%RH
1	API	White powder	White powder
2	API: Sucrose	White crystalline powder	White crystalline powder
3	API: Sodium Lauryl Sulphate	White powder	White powder
4	API: Xanthan Gum	White to off white powder	White to off white powder
5	API: Sodium Benzoate	White powder	White powder
6	API: Colloidal Silicon Dioxide	White powder	White powder
7	API: Saccharin Sodium	White crystalline powder	White crystalline powder
8	API: Colour Sunset Yellow FCF	Orange colour powder	Orange colour powder
9	API: Citric Acid Monohydrate	White crystalline powder	White crystalline powder
10	API: Simethicone Emulsion 30%	Wet mass	Wet mass
11	API: Flavour Mango RSV	Wet mass	Wet mass
12	API: Purified Water	Wet mass	Wet mass

As per physical observation there is no change in any colour of API excipient combination after 15 days at stability condition 25°C/60% RH and 40°C/75% RH.

Table no.4

Related substance
Sr. No.	API: Excipients Details	25°C/60%RH				40°C/75%RH
Sr. No.	API: Excipients Details	2,3 dimethyl aniline	% Any individual unknown impurity	% Total unknown impurity	% Total Impurity	% 2,3 dimethyl aniline	Any individual unknown impurity %	% Total unknown impurity	% Total Impurity
2	API: Sucrose	BDL	0.026	0.026	0.026	BDL	0.023	0.023	0.023
3	API: Sodium Lauryl Sulphate	BDL	0.024	0.024	0.024	BDL	0.028	0.028	0.028
4	API: Xanthan Gum	BDL	0.026	0.026	0.026	BDL	0.024	0.024	0.024
5	API: Sodium Benzoate	BDL	0.018	0.019	0.019	BDL	0.014	0.014	0.014
6	API: Colloidal Silicon Dioxide	BDL	0.029	0.029	0.029	BDL	0.029	0.029	0.029
7	API: Saccharin Sodium	BDL	0.027	0.048	0.048	BDL	0.026	0.030	0.030
8	API: Color Sunset Yellow FCF	BDL	0.023	0.023	0.023	BDL	0.024	0.024	0.024
9	API: Citric Acid Monohydrate	BDL	0.038	0.049	0.049	BDL	0.032	0.035	0.035
10	API: Simethicone Emulsion 30%	BDL	0.022	0.022	0.022	BDL	0.022	0.022	0.022
11	API: Flavor Mango RSV	BDL	0.033	0.037	0.037	BDL	0.020	0.020	0.200
12	API: Purified Water	BDL	0.034	0.034	0.034	BDL	0.023	0.033	0.033

B) Related substance after 15 days:

The related substance of drug excipient combinations was tested for Related substance. The result at stability condition 25°C/60% RH and 40°C/75%RH were summarized in following Table no.4.

API excipients combination were tested for Related Substance. All impurities limit was within the limit. Based on the physical observation and related substance study there is no possible drug excipient interaction. Hence forth above excipients were used for the further formulation and development study of Mefenamic acid suspension.

FORMULATION DEVELOPMENT STUDY^13,14

methodology:

Step 1: Weigh all the ingredient accurately. Take specific quantity of purified water, boil it, dissolve sugar and filter it through Hyflow supercell by preparing base (Filtering aid). Now cool the syrup at room temperature. Add Sucrose laurate, heat it up to 55^oC and maintained at constant temperature until it gets dissolved completely. Now add weighted quantity of Mefenamic acid. Stir for 45min to 1hr. under mechanical stirrer continuously. Now homogenized for 5-7min. add given quantity of simethicone (antifoaming agent).

Step 2: Take specific quantity of purified water, add Veegum k stir it for ½ to 1hr. check pH. Add step 2 in step 1 slowly under stirring. Continuously stir under mechanical stirrer for 15 to 30min. Homogenized for 5 min.

Step 3: Take specific quantity of purified water, add weighted quantity of Carbopol 974 P. stir for ½ hr. Add Xanthan gum and stir it to form a paste. Add step 3 in step 1 slowly under stirring. Continuously stir under mechanical stirrer for 15 to 30 min. Homogenized for 5 to 7min.

Step 4: Take weighted quantity of Sodium saccharin and Sodium benzoate, add step 4 in step 1 slowly under continuously mechanical stirring until dissolved it. Now add coloring and flavoring agent. Stir for 5 to 10 min. Make volume of suspension up to required quantity by using purified water. Check pH of suspension, adjusted to 4.30 by using Citric acid monohydrate.

Table No. 5: Formulations of Mefenamic acid suspension

	Quantity in Percent (%)
INGRADIENT	F1	F2	F3	F4	F5	F6	F7	F8	F9
Mefenamic acid	2.00	2.00	2.00	2.00	2.00	2.00	2.00	2.00	2.00
Sucrose	50.00	50.00	50.00	50.00	50.00	50.00	50.00	50.00	50.00
Xanthan gum	0.15	0.15	0.15	0.05	0.05	0.10	0.05	0.05	0. 15
Carbopol 974 P	0.30	0.20	0.20	0.30	0.30	0.25	0.20	0.20	0.30
Aluminum magnesium silicate (Veegum K)	1	1	0.5	1	0.5	0.75	0.5	1	0.50
Sodium benzoate	0.20	0.20	0.20	0.20	0.20	0.20	0.20	0.20	0.20
Sodium saccharin	0.10	0.10	0.10	0.10	0.10	0.10	0.10	0.10	0.10
Sucrose Laureate	0.05	0.05	0.05	0.05	0.05	0.05	0.05	0.05	0.05
Citric acid monohydrate	0.072	0.072	0.072	0.072	0.072	0.072	0.072	0.072	0.072
Color sunset yellow supra	0.020	0.020	0.020	0.020	0.020	0.020	0.020	0.020	0.020
Simethicone 30% dispersion	0.20	0.20	0.20	0.20	0.20	0.20	0.20	0.20	0.20
Mango flavor RSV IFF	0.40	0.40	0.40	0.40	0.40	0.40	0.40	0.40	0.40
Hyflow supercell	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S
Purified water	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S	Q.S

Characteristics of Mefenamic acid suspension:

pH of suspension:

The pH of suspension determined by pH Meter S20 (Mettler Toledo) using adequate amount of the sample¹⁵.

Determination of viscosity:

The viscosity of suspension was determined at ambient condition (DV II⁺, Brookfield Viscometer sp. 60rpm at 25⁰C) using adequate amount of the sample.

Weight/mL:

Weight per ml was of all batch’s formulation (F1-F9) measured by thoroughly clean and dry calibrated pycnometer.

In-vitro release of suspension:

The dissolution studies were conducted using USP XXIII apparatus type 2. A suspension equivalent to 100 mg of the drug was introduced into the dissolution medium (900ml of 0.05M Tris buffer, maintained at a temperature of 37°C±0.5°C), and stirred at 75rpm using a rotating paddle. Samples of 10 ml were withdrawn at appropriate intervals, filtered through Whatman filter paper no. 41, diluted, and analyzed at 286 nm using a UV spectrophotometer¹⁶.

Taste evaluation:

The taste evaluation of the suspension was conducted using a panel method involving 10 human volunteers. Each volunteer held 5ml of suspension, containing 100 mg of the drug, on their tongue for 60 seconds, after which the taste was assessed^17-18.

Assay of suspension:

Transfer 5 ml of the suspension into a 100ml volumetric flask and adjust the volume to 100ml with 0.05M Tris buffer. Sonicate the mixture for 10 to 15minutes and filter it. Next, withdraw 5ml of the filtered solution and transfer it into a 50ml volumetric flask, adjusting the volume to 50ml with 0.05 M Tris buffer. From this flask, withdraw 1ml of solution and transfer it into a 10ml volumetric flask, making up the volume to 10ml with 0.05M Tris buffer. Finally, measure the absorbance at 286nm using a UV spectrophotometer.

Top of Form

Bottom of Form

Sedimentation Rate:

The sedimentation volume of the prepared suspensions was used to assess their physical stability. Every suspension trial was measured in a 50ml graduated stopping cylinder. Three full turns upside down helped to properly disperse the suspension. The volume of sediment was then measured after the suspension had settled for three minutes. This is the sediment's initial volume (H₀). For fourteen days, the cylinder was left undisturbed. The final volume of sediment was determined by reading the volume of sediment at one hour on the fourteenth day (Hu)^19-23.

RESULT AND DISCUSSION:

Formulation F1 was prepared with high concentration as compared to optimized batch (F6) which may provide no bitter taste, difficult to pourable and high viscosity. Formulation F2 was prepared with high concentration as compared to F6 which may provide no bitter taste, high viscosity which was difficult to pourable. Formulation F3 was prepared with less concentration of Veegum K and Carbopol 974P and more concentration of Xanthan gum which may provide optimum viscosity and bitterness. Formulation F4 was prepared with less concentration of Xanthan gum and more concentration of Carbopol 974P and Veegum K which may provide low viscosity, sedimentation, phase separation, no bitter in taste. Formulation F5 was prepared with less concentration of Veegum K and Xanthan gum and more concentration of Carbopol 974P which may provide bitterness to formulation, sedimentation, phase separation, low creaming observed. Formulation F6 showed no sedimentation, no bitter taste, no phase separation, or no creaming, easily pourable. Formulation F7 was prepared with less concentration of Xanthan gum and high concentration of Veegum K and Carbopol 974P which may provide optimum viscosity, phase separation and sedimentation. Formulation F8 was prepared with less concentration of Xanthan gum and Carbopol 974P and high concentration of Veegum K which may provide sedimentation, slightly bitter in taste, low viscosity as compared to F6, slightly phase separation. Formulation F9 was prepared with less concentration of Xanthan gum and high concentration of Carbopol 974P and concentration of Veegum K which is high in F9 which may provide sedimentation and phase separation. Weight/mL of all formulations show suitable results, but F6 provides top result in this study

Table no.6: Evaluation parameter of Mefenamic acidsuspension

PARAMETERS	F1	F2	F3	F4	F5	F6	F7	F8	F9
Color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color	Orange/ Mango color
pH	5.30	3.30	3.50	5.45	5.00	4.30	4.55	5.50	4.55
Viscosity	350	330	310	295	280	306	285	290	330
Assay %	101.01	99.06	98.96	99.45	98.56	100.01	97.24	101.85	99.31
Sedimentation rate	0.98	0.95	0.96	0.97	0.98	0.97	0.96	0.97	0.98
Weight/mL	1.2658	1.2657	1.2654	1.2550	1.2563	1.2564	1.2551	1.2556	1.2449

Table no.7: Evaluation of taste of Mefenamic acid suspension

Formulation	Volunteers
Formulation	I	II	III	IV	V	VI	VII	VIII	IX	X
F1	1	1	0	1	2	1	2	0	2	1
F2	0	1	1	2	0	2	1	1	0	2
F3	4	3	5	4	4	3	3	5	5	4
F4	2	3	1	0	2	1	0	2	1	2
F5	4	5	3	3	5	4	3	3	4	5
F6	0	0	1	0	1	0	0	1	1	0
F7	2	3	4	5	3	4	3	5	4	3
F8	2	2	1	2	1	1	2	3	1	2
F9	3	4	5	2	3	5	2	3	4	3

0=Pleasant, 1=Tasteless, 2=No bitter but after taste give bitterness, 3=immediately gives bitterness, 4=slightly bitter, 5=extremely bitter

Table no.8: Evaluation of physical parameter of Mefenamic acid suspension by visual observation

PARAMETERS	F1	F2	F3	F4	F5	F6	F7	F8	F9
Bitterness	No	No	Yes	No	Yes	No	Yes	No	Yes
Sedimentation	No	No	Slight	Yes	Yes	No	Yes	Yes	No
Phase separation	Yes	No	No	Yes	Yes	No	Yes	Yes	Yes
Viscosity	Highly Viscous, Difficult to pourable	Highly Viscous, Difficult to pourable	Optimum Viscosity, Easily pourable	Low Viscosity	Low Viscosity	Optimum	Low Viscosity	Low Viscosity	High Viscous, Difficult to pourable

pH 9.0 Tris Buffer
Apparatus: Paddle		RPM: 50		Volume: 900 ml
Time (Min)	1	2	3	4	5	6	Mean
5	18.49	25.85	24.06	26.83	23.39	27.66	24.38
15	37.07	49.62	45.27	51.61	48.19	49.88	46.94
30	60.59	79.24	71.97	80.58	77.16	77.22	74.46
45	80.33	97.06	89.99	96.28	95.66	96.31	92.6
60	92.43	105.05	99.48	101.16	103.57	104.24	100.99

In Vitro Dissolution study

Fig.1 The in vitro drug release of F6 formulation

CONCLUSION:

Many parents are faced the daily challenge of getting their children to take medicine. Children are frequently failed to take medications properly because of unpleasant taste of medicament. Non-compliance can lead to worsening of diseased condition. Use of Carbopol 974 P and Veegum K offers adsorption method. Drug adsorbed or entrapped in the matrix of the porous component, which may result in a delayed release of the bitter active during the transit through the oral cavity thereby achieving taste masking. In this technique, adsorbents of the bitter drugs are prepared by adsorption process. This process involves the adsorption of the drug solution using insoluble materials like Veegum, Bentonite etc

ACKNOWLEDGEMENTS:

We are grateful to the Zuventus Healthcare Ltd for providing the necessary resources, facilities, and infrastructure essential for conducting this research. We acknowledge with gratitude all those who have contributed directly or indirectly to the completion of this research paper. Your collective efforts have been integral to its success, and we are deeply appreciative of your contributions.

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Received on 02.08.2024 Revised on 11.11.2024

Accepted on 01.01.2025 Published on 03.03.2025

Available online from March 07, 2025

Asian J. Res. Pharm. Sci. 2025; 15(1):1-6.

DOI: 10.52711/2231-5659.2025.00001

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