Background: Oral Drug Delivery is the Most Preferred and
Convenient route of Drug administration due to High Patient Compliance,
Cost-effectiveness, Flexibility in the Design of Dosage form and Ease of
Production. Many Patient Groups Such as Elderly children, Mentally Retarded
have difficulty in swallowing. Conventional dosage forms like Tablets will be
further hindered by Conditions such as the Unavailability of water, Allergic
reactions and Episodes of Coughing. Hence, these problems can be Solved by
Developing Rapidly Disintegrating and Dissolving Tablet dosage forms for Oral
administration because they Dissolve in saliva and do not Require water for
swallowing.
Aim: Tramadol Hydrochloride is a Centrally Acting Synthetic
Opioid Analgesic. The aim of the present study was to Formulate Mouth
Dissolving Tablets of Tramadol Hydrochloride.
Methods: The Tramadol Hydrochloride Mouth Dissolving Tablets
were prepared by Direct Compression and Wet Granulation Methods. The
Composition of the Present Study includes Tramadol Hydrochloride, Mannitol,
Crospovidone, Copovidone, Ethyl Cellulose, Silicon dioxide and Magnesium
stearate. The initial Four batches (TM1-TM4) were Formulated by the Direct
Compression Method and (TM5- TM13) were Formulated by the Wet Granulation
Method. With the Same Composition. Physico-chemical Parameters include
Hardness, Friability [1] Weight Variation Disintegration Time and Dissolution
Studies were Determined for all the Invitro Drug Release Studies and Stability
Studies were Performed with the Same Composition as that of the Reference
Product (Rybix, ODT).
Results: The Results indicate that the Hardness of the
Tablet Prepared by Direct Compression and Wet Granulation Methods has increased
with an increase in the concentration of Super Disintegrating Agents like
Crospovidone, Copovidone and also Pharmaburst. In the case of Disintegration
Time TM13 was considered to be the Best Formulation for 15 sec and TM01 is
considered to be the Poor formulation for 104 sec because of its Hardness and
More Porous structure. The Trial TM11 is considered as Optimized Formulation as
part of Dissolution and Flow Properties.TM11-TM13 was Formulated and given to 5
human volunteers to study the Organoleptic Characters. The Stability Studies
[2] Indicate that the Drug is stable for a period of 3 months.
Conclusion: By Considering all the Results and Stability
Data, it was concluded that Trial TM13 is the most Stable and met the
Predetermined Specifications Of Dissolution, Assay, Friability, Disintegration
Time Dispersion Time and stability for a period of 3 months.
Author(s) Details:
Dr. Raja Narender B.
Department of Pharmaceutics, CVM College of Pharmacy, Velichala,
Kothapaally, Karimnagar, India.
T. Gayathri
Department of Pharmaceutics, CVM College of Pharmacy, Velichala,
Kothapaally, Karimnagar, India.
Please see the link here: https://stm.bookpi.org/ACPR-V9/article/view/14367
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