Akter et al Journal of Drug Delivery & Therapeutics. 2021; 11(3-s):1-6
ISSN: 2250-1177 [1] CODEN (USA): JDDTAO
Available online on 15.06.2021 at http://jddtonline.info
Journal of Drug Delivery and Therapeutics
Open Access to Pharmaceutical and Medical Research
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Open Access Full Text Article Short Communication
Formulation and In-Vitro Evaluation of Orally Disintegrating Tablets (ODTs)
of Tramadol Hydrochloride
Jesmin Akter
1
, Nusrat Ahmed
2
*, Sabrina Rahman Archie
2
1
Department of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
2
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
Article Info:
___________________________________________
Article History:
Received 19 April 2021
Reviewed 23 May 2021
Accepted 28 May 2021
Published 15 June 2021
___________________________________________
Cite this article as:
Akter J, Ahmed N, Archie SR, Formulation and In-Vitro
Evaluation of Orally Disintegrating Tablets (ODTs) of
Tramadol Hydrochloride, Journal of Drug Delivery
and Therapeutics. 2021; 11(3-S):1-6
DOI: http://dx.doi.org/10.22270/jddt.v11i3-S.4875
Abstract
______________________________________________________________________________________________________
Since orally disintegrating tablets (ODTs) of tramadol hydrochloride are not available in
the market, so an attempt has been taken to formulate and evaluate ODT preparation of
tramadol hydrochloride. In this present work, direct compression was the technique used
for preparing ODT using superdisintegrants like croscarmellose sodium, sodium starch
glycolate and crospovidone at different concentrations. Prepared formulations were
evaluated for various quality parameters- angle of repose, Carr’s index, Hausner ratio,
weight variation, friability, hardness, drug content, dispersion time, wetting time and in-
vitro dissolution. The angle of repose data indicated that the flow property of all the
formulations was good to excellent. Comparing with the specifications, the results of Carr's
index (%) and Hausner’s ratio indicated that the flowability of all the formulations blend
was significantly good. Prepared formulations showed average wetting time ranging from
40-45 seconds, average dispersion time with 3-6 minutes. In-vitro dissolution profile
indicated the cumulative % drug release between 30-80% for most of the cases.
Keywords: Orally disintegrating tablets, Tramadol hydrochloride, Superdisintegrants,
Direct compression.
*Address for Correspondence:
Nusrat Ahmed, Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh.
ORCID ID: https://orcid.org/0000-0002-6059-0247
INTRODUCTION
Many patients like pediatric and geriatric, disabled,
bedridden or uncooperative, face difficulties while taking
traditional dosage forms like tablets due to swallowing
problem. Orally disintegrating tablets (ODTs) can be a better
alternative for these kind of patients, as they are more
convenient and patient compliant. Orally disintegrating
tablet rapidly disintegrates and dissolves in saliva when
placed upon tongue and does not require additional water
for swallowing.
1, 2
United States Food and Drug Administration (FDA) defined
ODT as “A solid dosage form containing medicinal substance
or active ingredient which disintegrates rapidly usually
within a matter of seconds when placed upon the tongue”.
European Pharmacopeia used the term orodispersible
tablets and defined as a tablet that when placed in the mouth
disperses within 3 minutes before swallowing.
3, 4
The aim of this study was to formulate ODTs to achieve rapid
disintegration in the mouth without water. Study was
designed by using different superdisintegrates-
croscarmellose sodium, sodium starch glycolate and
crospovidone at different concentrations to evaluate their
effect on various quality parameters. Tramadol
hydrochloride was selected as the model drug in the study.
Tramadol is a centrally acting, synthetic opioid analgesic,
which is used to treat moderate to severe pain like
postoperative pain, traumatic pain and cancer pain. It is
rapidly absorbed after oral administration with mean
bioavailability of approximately 75%. Its onset of action is
occurred within 30-60 minutes and elimination half-life is
about 6 hours.
1, 5, 6
The capsule dosage form and sustained release tablet of
tramadol hydrochloride are available in Bangladesh for oral
administration. There is no marketed ODT preparation in
Bangladesh, but in USA and Europe tramadol hydrochloride
ODT preparations are currently available. Thus, in this work
an attempt has been taken to formulate and evaluate orally
disintegrating tablets of tramadol hydrochloride.
MATERIALS AND METHODS
Materials:
Tramadol hydrochloride API (Active Pharmaceutical
Ingredient) was obtained from Beximco Pharmaceuticals Ltd.
as a gift sample. Other excipients were obtained from
Pharmaceutical Technology Lab, University of Dhaka. Nine