Ramya, S (2021) Formulation and Standardization of Antiemetic Herbal Lozenges as per Ayush and Pharmacopoeial Standards. Masters thesis, Periyar College of Pharmaceutical Sciences, Tiruchirappalli.
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Abstract
Lozenges are medicated dosage forms that have been developed about 20th century ago and are available under commercial production. They are very economic dosage form designed for local as well as systematic therapy. A wide range of activity can be incorporated in this dosage form with the advantage of administration to paediatric and geriatric population with pleasant taste and easy swallowing. Herbal medicines are found to be effective treatment for various ailments that the major lacuna is lack proper scientific validation. The present study was aimed in investigating the selected plant Rumex vesicarius Linn. for the formulation and standardization of herbal lozenges. ❖ Authentication of plant material plays a key role in pharmacognostical studies. The plant Rumex vesicarius Linn. was authenticated by Dr. V. Nandagopalan, Associate professor, Department of Botany, National College, Tiruchirappalli, Tamil Nadu. ❖ The Macroscopy and physicochemical parameters were studied to establish data for proper authentication and detection of adulterants. From the quantitative analysis of toxic heavy metals like Lead, Mercury, Cadmium and Arsenic, it is clear that they were within the WHO limits and ensures the safety of the drug. ❖ The preliminary phytochemical screening of the crude drug and formulated lozenges reveals the presence of constituents like Carbohydrates, Protein, Steroids, Alkaloids and Flavonoids. ❖ The herbal raw material and formulated Lozenge’s were analysed for their identity, quality and purity. The standardization of Raw material was done as per AYUSH guidelines The selection of herbal formulation was done by analysing various physiochemical parameters. ❖ The physicochemical constant like Loss on drying, Ash value, Extractive value and pH were determined, which will help in preventing variation in quality of the drug. ❖ The heavy metal analysis and the microbial load analysis were carried out as per the WHO guidelines to check its limit. The results were found to be within the limits. ❖ FTIR spectroscopic studies were carried out in order to establish compatibility between drug and excipients. The results concluded that there was no chemical interaction between drug and excipients used, so they could be used for formulation of Rumex vesicarius Linn. lozenges. ❖ The weight of formulated Hard candy Lozenges are within the accepted range of 1.5 to 4.5g. Result obtained from weight variation does not deviate from the average weight by more than 5%. Friability was found to be less than 1%. ❖ The optimized lozenges F1 shows acceptable disintegration time of 90 Sec which is acceptable for lozenges. The drug content of the lozenges of F1 series are in the range and the correlation of variation was found to be less than 0.010%, indicating uniformity of drug content in the prepared lozenges F1. Moisture content also found to be with in the acceptable limit. The pH of both F1 and F2 lozenges were found to be in the acceptable range of 5.0 to 6.0. ❖ The formulated lozenges F1 shows dissolution rate of more than 95.0% in 30 minutes, which meets the criteria for selection of F1 formulation for further studies. This shows that formulations containing between 55 - 65% sugar and 35 - 45% corn syrup solids generally offer the best compromise among the resistance to graining, reduction of moisture absorption and realistic preparation time. ❖ HPTLC fingerprinting profile shows common bands in both crude drug and formulated lozenges F1 which assures the purity of the formulated Rumex vesicarius Linn. hard candy Lozenges. Accelerated stability studies were carried out as per ICH guidelines for the period of 3 months. The resultant stability date shows that the formulation is more stable under accelerated stability condition. ❖ The lozenges were formulated and evaluated by all the above parameters and the following conclusions were made from the studies. ❖ Finally, it can be concluded that, considering the ease of preparation, attractiveness and the drug release characteristics, hard candy Rumex vesicarius Linn. lozenges after optimization and standardization are ideal and attractive alternative for allopathic antiemetic drugs.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.261930152 |
| Uncontrolled Keywords: | Formulation, Standardization, Antiemetic Herbal Lozenges, Ayush and Pharmacopoeial Standards. |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Subramani R |
| Date Deposited: | 24 May 2023 01:50 |
| Last Modified: | 24 May 2023 01:50 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21267 |
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