Volume 03 Issue 05-2023
1
American Journal Of Biomedical Science & Pharmaceutical Innovation
(ISSN
–
2771-2753)
VOLUME
03
ISSUE
05
Pages:
01-04
SJIF
I
MPACT
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.
Volume 03 Issue 05-2023
2
American Journal Of Biomedical Science & Pharmaceutical Innovation
(ISSN
–
2771-2753)
VOLUME
03
ISSUE
05
Pages:
01-04
SJIF
I
MPACT
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
Volume 03 Issue 05-2023
3
American Journal Of Biomedical Science & Pharmaceutical Innovation
(ISSN
–
2771-2753)
VOLUME
03
ISSUE
05
Pages:
01-04
SJIF
I
MPACT
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
Volume 03 Issue 05-2023
4
American Journal Of Biomedical Science & Pharmaceutical Innovation
(ISSN
–
2771-2753)
VOLUME
03
ISSUE
05
Pages:
01-04
SJIF
I
MPACT
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.
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