Design and Evaluation of Oro-Dispersible Tablets of Tramadol Hydrochloride | Chapter 8 | Advanced Concepts in Pharmaceutical Research Vol. 9

 

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

Design, Charecterization of Imidapril Mouth Dissolving Tablets Using Super Disintegrants | Chapter 10 | Advanced Concepts in Pharmaceutical Research Vol. 4

 Objective: The aim concerning this study was preparing once daily opening disintegrating tablets to handle surely for adult hypertensive patients who have trouble in swallowing.Background: The spoken bioavailability of Imidapril can be enhanced by dropping off its in consideration of first pass effect. Mouth dissolving medicine formulation has been widely and favorably applied to advance the dissolution, solubility, and consequently the bioavailability of poorly water-dissolved drugs.Methods: Imidapril mouth annulling tablets (MDTs) were prepared by direct condensation method using various concentrations of synthetic super disintegrants that is to say Sodium starch glycolate, Croscarmellose sodium & Kyron T-314. The prepared tablets were judged for weight difference, thickness, hardness, friability, content consistency, disintegration time and In-vitro separation studies.Results: The micropolitics study indicates that all formulations were of agreeable to good flowability. Tablet hardness and friability pointed out that the prepared formulations were having good machinelike strength. Ultimate satisfactory formulation F5 holding Sodium starch glycolate showed minimum decomposition time of 19 s and released a maximum amount of drug in 30 brief time period in phosphate buffer 6.8pH, by an appropriate consolidation of excipients. The optimized F5 formulation holding Sodium starch glycolate was found expected stable all the while stability studies conducted for 3 mo as per Worldwide Conference on Harmonization (ICH) directions. The dissolution rate was establish to be increased linearly accompanying increase in the concentration of super disintegrant. The examined super disintegrants can be ordered based on the overall in-vitro release description of Imidapril Mouth dissolving pill i.e. Sodium starch glycolate>Kyron T314>Croscarmellose sodium.Decision: The present study finally proved that Imidapril MDTs could be favorably developed using miscellaneous super disintegrants. The processed tablets gave promising results concerning the faster release of Imidapril. Further clinical studies are suggested to ratify the ability of the best-obtained system to prevent the first pass metabolism of Imidapril and improve patient agreement.

Author(s) Details:

Ismail Y.,
Crescent School of Pharmacy, B. S. Abdur Rahman Crescent Institute of Science and Technology, Vandalur, Chennai, Tamil Nadu, India.

V. Vijaya Kumar,
Crescent School of Pharmacy, B. S. Abdur Rahman Crescent Institute of Science and Technology, Vandalur, Chennai, Tamil Nadu, India

Please see the link here: https://stm.bookpi.org/ACPR-V4/article/view/13005