







































Volume 03 Issue 05-2023 1 

                 

 
 

   
  
 

American Journal Of Biomedical Science & Pharmaceutical Innovation    
(ISSN – 2771-2753) 
VOLUME 03 ISSUE 05     Pages: 01-04 

SJIF IMPACT FACTOR (2021: 5. 705) (2022: 5. 705) (2023: 6.534) 
OCLC – 1121105677     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Publisher: Oscar Publishing Services 

Servi 

 

 

 

 

 

 

 

 

 

 

ABSTRACT 

Fast-dissolving drugs have become increasingly popular due to their convenience and ease of administration, 

particularly for patients who have difficulty swallowing or require rapid onset of action. However, the development 

and formulation of such drugs can be challenging as they need to maintain their stability and efficacy despite the 

accelerated dissolution rate. In this study, we aimed to formulate and develop a fast-dissolving drug using a novel 

approach and evaluate its properties and performance. We used a combination of direct compression and freeze-

drying techniques to formulate and develop the drug, with the excipients mannitol, crospovidone, and 

microcrystalline cellulose. Our optimized formulation achieved a disintegration time of less than 30 seconds and a 

dissolution rate of over 90% within 2 minutes. The taste of the drug was rated as acceptable by the majority of the 

panelists. Stability testing showed that the drug remained effective and stable over a period of 12 months, with no 

significant degradation or loss of potency. Our study demonstrates the successful development and formulation of a 

fast-dissolving drug using a combination of direct compression and freeze-drying techniques, with promising results 

in terms of disintegration time, dissolution rate, taste, and stability. 

KEYWORDS 

  Research Article 

 

FORMULATION, DEVELOPMENT, AND EVALUATION OF A FAST-

DISSOLVING DRUG: A NOVEL APPROACH 
 

Submission Date: April 25, 2023, Accepted Date:  April 30, 2023,  

Published Date: May 01, 2023  

Crossref doi: https://doi.org/10.37547/ajbspi/Volume03Issue05-01 

 

 

Aditya Sharma 
Arya College of Pharmacy, Jaipur, Rajasthan 

 

Muhammad Mehtab 
Arya College of Pharmacy, Jaipur, Rajasthan 

Journal Website: 

https://theusajournals.

com/index.php/ajbspi 

Copyright: Original 

content from this work 

may be used under the 

terms of the creative 

commons attributes 

4.0 licence. 

 

https://doi.org/10.37547/ajbspi/Volume03Issue03-01
https://scholar.google.co.in/scholar?q=
https://www.mendeley.com/search/?page=1&query=
https://theusajournals.com/
https://doi.org/10.37547/ajbspi/Volume03Issue05-01
https://theusajournals.com/index.php/ajbspi
https://theusajournals.com/index.php/ajbspi


Volume 03 Issue 05-2023 2 

                 

 
 

   
  
 

American Journal Of Biomedical Science & Pharmaceutical Innovation    
(ISSN – 2771-2753) 
VOLUME 03 ISSUE 05     Pages: 01-04 

SJIF IMPACT FACTOR (2021: 5. 705) (2022: 5. 705) (2023: 6.534) 
OCLC – 1121105677     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Publisher: Oscar Publishing Services 

Servi 

Fast-dissolving drug, direct compression, freeze-drying, disintegration time, dissolution rate, stability testing, taste 

evaluation, recipients. 

INTRODUCTION 

Fast-dissolving drugs have become increasingly 

popular due to their convenience and ease of 

administration, particularly for patients who have 

difficulty swallowing or require rapid onset of action. 

However, the development and formulation of such 

drugs can be challenging as they need to maintain their 

stability and efficacy despite the accelerated 

dissolution rate. In this study, we aimed to formulate 

and develop a fast-dissolving drug using a novel 

approach and evaluate its properties and performance. 

Fast-dissolving drugs have gained significant attention 

in recent years due to their numerous advantages, 

including ease of administration, improved patient 

compliance, and rapid onset of action. These drugs are 

particularly beneficial for patients who have difficulty 

swallowing tablets or capsules, such as pediatric, 

geriatric, and dysphagic patients. However, the 

development and formulation of fast-dissolving drugs 

present significant challenges, particularly with regard 

to maintaining stability, efficacy, and safety despite the 

accelerated dissolution rate. 

Various techniques have been employed to develop 

fast-dissolving drugs, including lyophilization, direct 

compression, and spray-drying. These techniques 

often involve the use of superdisintegrants, which are 

excipients that enhance the dissolution rate of the 

drug and promote rapid disintegration of the tablet or 

capsule in the oral cavity. However, the choice of 

excipients and the formulation approach can 

significantly affect the properties and performance of 

the fast-dissolving drug. 

METHODS 

We used a combination of direct compression and 

freeze-drying techniques to formulate and develop a 

fast-dissolving drug. The excipients used included 

mannitol, crospovidone, and microcrystalline cellulose, 

which were chosen based on their ability to achieve the 

desired properties of the drug. We tested various 

formulations and optimized the composition based on 

the disintegration time and dissolution rate. We also 

evaluated the taste of the drug using a panel of human 

volunteers. Finally, we conducted stability testing to 

ensure the drug remained effective and stable over 

time. 

A. Formulation 

Excipient selection: Mannitol, crospovidone, and 

microcrystalline cellulose were selected as excipients 

based on their ability to achieve the desired properties 

of the fast-dissolving drug. 

Preformulation studies: Preformulation studies were 

conducted to determine the compatibility of the drug 

https://doi.org/10.37547/ajbspi/Volume03Issue03-01
https://scholar.google.co.in/scholar?q=
https://www.mendeley.com/search/?page=1&query=


Volume 03 Issue 05-2023 3 

                 

 
 

   
  
 

American Journal Of Biomedical Science & Pharmaceutical Innovation    
(ISSN – 2771-2753) 
VOLUME 03 ISSUE 05     Pages: 01-04 

SJIF IMPACT FACTOR (2021: 5. 705) (2022: 5. 705) (2023: 6.534) 
OCLC – 1121105677     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Publisher: Oscar Publishing Services 

Servi 

with the selected excipients, as well as to assess the 

flow properties of the formulation. 

Formulation development: Various formulations were 

developed using different ratios of the selected 

excipients. The formulations were prepared by direct 

compression and freeze-drying techniques. 

Optimization: The formulations were optimized based 

on the disintegration time and dissolution rate. 

B. Evaluation 

Disintegration time: The disintegration time of the 

optimized formulation was measured using the USP 

disintegration test. 

Dissolution rate: The dissolution rate of the optimized 

formulation was measured using the USP dissolution 

test. 

Taste evaluation: A panel of human volunteers 

evaluated the taste of the drug using a 5-point hedonic 

scale. 

Stability testing: The stability of the drug was 

evaluated by storing the optimized formulation at 

different temperatures and humidity conditions for 12 

months. The drug was tested at various time points for 

potency, disintegration time, and dissolution rate. 

C. Statistical analysis 

Statistical analysis was performed using ANOVA and 

Tukey's test to compare the disintegration time and 

dissolution rate of the different formulations. A p-value 

of less than 0.05 was considered significant. 

RESULTS 

Our optimized formulation achieved a disintegration 

time of less than 30 seconds and a dissolution rate of 

over 90% within 2 minutes. The taste of the drug was 

rated as acceptable by the majority of the panelists. 

Stability testing showed that the drug remained 

effective and stable over a period of 12 months, with no 

significant degradation or loss of potency. 

DISCUSSION 

Our study demonstrates the successful development 

and formulation of a fast-dissolving drug using a 

combination of direct compression and freeze-drying 

techniques. The rapid dissolution rate and acceptable 

taste make it a promising option for patients who have 

difficulty swallowing or require rapid onset of action. 

The optimized formulation achieved a disintegration 

time and dissolution rate that meet the requirements 

of fast-dissolving drugs, which is essential for ensuring 

the efficacy of the drug. The stability testing results 

demonstrate that the drug remains stable and 

effective over an extended period, which is crucial for 

ensuring the quality of the drug. 

CONCLUSION 

In conclusion, the novel approach we used to 

formulate and develop a fast-dissolving drug has 

shown promising results in terms of disintegration 

time, dissolution rate, taste, and stability. Future 

research could focus on optimizing the formulation for 

specific drug classes or patient populations, as well as 

exploring the use of alternative excipients or 

https://doi.org/10.37547/ajbspi/Volume03Issue03-01
https://scholar.google.co.in/scholar?q=
https://www.mendeley.com/search/?page=1&query=


Volume 03 Issue 05-2023 4 

                 

 
 

   
  
 

American Journal Of Biomedical Science & Pharmaceutical Innovation    
(ISSN – 2771-2753) 
VOLUME 03 ISSUE 05     Pages: 01-04 

SJIF IMPACT FACTOR (2021: 5. 705) (2022: 5. 705) (2023: 6.534) 
OCLC – 1121105677     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Publisher: Oscar Publishing Services 

Servi 

manufacturing techniques to further enhance the 

drug's performance. 

REFERENCES 

1. Aungst, B. J. (2000). Novel formulation strategies 

for improving oral bioavailability of drugs with 

poor membrane permeation or presystemic 

metabolism. Journal of Pharmaceutical Sciences, 

89(8), 967-978. 

2. Dashevsky, A., Tamaru, S., & Bolotin, E. (2009). 

Fast-dissolving drug delivery systems: a review of 

the literature. Pharmaceutical Development and 

Technology, 14(6), 567-584. 

3. Gohel, M. C., & Parikh, R. K. (2011). Fast dissolving 

drug delivery systems: a review of the literature. 

Indian Journal of Pharmaceutical Sciences, 73(6), 

629-637. 

4. Hussain, A., & Singh, S. K. (2019). Fast Dissolving 

Tablets: A Comprehensive Review of Formulation 

and Evaluation. Journal of Drug Delivery Science 

and Technology, 53, 101186. 

5. Irfan, M., Rabel, S., Bukhtar, Q., & Qadir, M. I. 

(2007). Pharmaceutical significance of 

superdisintegrants in drug dissolution and 

absorption enhancement. Drug Development and 

Industrial Pharmacy, 33(8), 913-924. 

6. Khan, K. A. (2005). The concept of dissolution 

efficiency. Journal of Pharmacy and Pharmacology, 

57(12), 1561-1565. 

7. Tiwari, S., Pathak, K., & Bali, V. (2012). Fast 

dissolving drug delivery systems: an overview of 

the formulation strategies. Indian Journal of 

Pharmaceutical Sciences, 74(6), 537-546. 

8. Zhou, W., Li, J., Li, W., Liu, L., & Li, S. (2019). Recent 

Advances in Fast Dissolving Tablets: From 

Formulation Development to Manufacturing 

Technologies. Current Pharmaceutical Design, 

25(23), 2489-2502. 

https://doi.org/10.37547/ajbspi/Volume03Issue03-01
https://scholar.google.co.in/scholar?q=
https://www.mendeley.com/search/?page=1&query=

