A chewable metronidazole soft candy lozenges preparation

Abstract

Title: A Chewable Metronidazole Soft Candy Lozenges Preparation Metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes gelato- glycerine base by heating gelatine with sucrose syrup and glycerin with continuous stirring uniformly mixed in clockwise manner of propylene glycol 400, methyl paraben and favoring agent in a sequential manner, introduced to previously greased mould in refrigerator for 6-7 hrs, demoulded to prepared final soft candy lozenges.

Description

Field of the InventionThe present invention relates to pharmaceutical preparation comprises of soft candy lozenges preparation of metronidazole using heating and congealing method from Gelato-glycerine base method effectively used in oropharynx thrush.Background of InventionLozenges, which dissolve or disintegrate in the mouth or throat, are flavored medicinal dosage forms that contain one or more drugs, usually in a sweetened foundation. Lozenges prescribed for individuals those have difficulty in swallowing oral dosage forms and for drugs that are meant for releasing gradually into the mouth to maintain a steady level of medication and coat the tissues in the throat with the drug. Lozenges accustomed to administer medications specifically in patient's oral cavity or by swallowing drug afterwards it has dissolved in saliva. Lozenges can contain one or several pharmaceuticals. Lozenges have two main effects:1. Localized : at a specific location within the oropharyngeal cavity.2. Systemic: where the drug circulates in the bloodstream and manifests its pharmacological action.The medicinal lozenges have the advantage of prolonging the dosage form's retention period in the oral cavity, which boosts bioavailability, lessens stomach discomfort, and avoids first-pass metabolism.Even though the lozenge takes around 30 minutes to dissolve, the patient determines how quickly the lozenge dissolves and absorbs the liquid by sucking on it till it melts. The purpose of lozenges is to dissolve gradually in mouth.Lozenges are a fantastic option for a patient-friendly dose form that is simple to take orally. Better patient compliance is ensured by the structure of the mouth andcheek, which favors both local and systemic absorption, particularly in the case of younger and older patients. This dosage form allows for the incorporation of large amounts. Prepared lozenges exhibit higher bioavailability, a quicker start of action, and less gastrointestinal discomfort by skipping first pass metabolism.Lozenges decrease the frequency of dose while increasing the combined drug's bioavailability. Drugs can be administered as lozenges to overcome the taste and texture of solid dosage forms, such as tablets and capsules, as well as swallowing difficulties caused by liquid dosage forms.Lozenges are medicated buccal tablets with flavor that are meant to be sucked and kept in the pharynx or mouth. They typically include one or more medications in a sweetened base.Lozenges are used to treat oropharyngeal symptoms, which are frequently brought on by local infections. If the medication is adequately received via mucosal linings or when swallowed, It will show systemic effect.Lozenges come in various shapes including flat circular, octagonal, square, and cylindrical.Based on their texture and content, lozenges can be categorized into four types: chewy or caramel-based medicated lozenges, soft lozenges, compressed tablet lozenges, and hard lozenges.Lozenges offer several key advantages. They taste pleasant and prolong the activity of medicine in the buccal cavity. They are easy to administer to both young and elderly patients and require minimal equipment for preparation. Unlike many other dosage forms, lozenges do not need to be taken with water. Importantly, if a dose is not needed, their intake can be easily halted. Additionally, they are a suitable option for individuals who have difficulty swallowing other solid dose forms.Lozenges have several disadvantages to consider. Firstly, there is a risk that children may mistake them for candy, which underscores the importance ofkeeping prescription drugs safely stored away from their reach. Secondly, lozenges containing oily substances can lose their intended texture over time. Lastly, if a lozenge becomes sticky, it may adhere to the buccal cavity, potentially causing discomfort or difficulty in removal. These factors highlight important precautions and considerations when using lozenges as a method of medication delivery. Disease Profile:Oropharyngeal thrush is an uncontrolled mucosal infection that is typically brought on by the fungus Candida albicans, although it can also be brought on by species including Candida glabrata, Candida tropicalis, and Candida krusei.Oropharyngeal thrush, or oral candidiasis, manifests in four primary varieties. Pseudomembranous thrush presents as discrete, white, curd-like lesions on a thickened surface after debris removal, appearing on the tongue, gingivae, buccal mucosa, and throat. Erythematous thrush exhibits fine patches of redness on the tongue dorsum, buccal mucosa, or palate. Hyperplastic thrush features white, adherent plaques or patches on the tongue, palate, or buccal mucosa that cannot be scraped off. Denture-induced stomatitis is characterized by smooth or granular redness limited to the denture-bearing area of the hard palate, often associated with angular cheilitis-red, fissured plaques in the corners of the mouth. These variations underscore the diverse clinical presentations and locations affected by oral candidiasis. The symptoms of oral candidiasis include a burning sensation on the tongue, a sore and painful mouth, which can impair speech, nutritional intake, and overall quality of life. Additionally, individuals may experience altered taste as a result of the infection.Treatment : Metronidazole (MZ) is a pillar medication used to treat anaerobic, protozoal, and microaerophilic bacterial infections.Spreading through microorganisms, it messes with DNA to prevent the synthesis of proteins, breaks down strands of DNA, and alters the structure of helical DNA before killing off bacterial cells. MZ is a cost-effective medication because of its pharmacodynamics and kinetics, ease of procurement, manageable profile of undesired side effects, and uninterrupted antibacterial impact.After oral treatment, metronidazole seems to be easily absorbed; it comes in a variety of forms, including cream, gel pills, and oral liquid. But in the current study, an effort was made to formulate metronidazole as lozenges in order to avoid any potential medication noncompliance.The present invention relates to a novel soft candy lozenges of metronidazole preparation prepared through heating and congealing method using Gelato-glycerine base with suitable polymer and additives effectively used in oropharynx thrush.Objective of InventionThe principal objective of the invention is to develop novel soft candy lozenges formulation of metronidazole to facilitate the local drug action and systemic effect through buccal absorption signifies therapeutic effects in oropharynx thrush.The secondary objective of the invention is that the metronidazole soft candy lozenges prepared from heating and congealing method using Gelato-glycerine base with propylene glycol 400 and sucrose. The further objective of the invention is that the prepared soft candy lozenges preparation evaluated for factorial design, % drug content, in vitro drug release, friability, and stability study to confirm the efficacy and stability of the preparation Summary of the InventionThe present invention relates to formulate novel soft candy lozenges of metronidazole prepared from heating and congealing method using Gelato-glycerine base with propylene glycol 400 and sucrose to facilitate the local drug action and systemic effect through buccal absorption signifies therapeutic effects in oropharynx thrush.A Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof: A) Gelato-glycerin base: heating gelatine from 12 to 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 to 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture; B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and flavoring agent in a sequential manner; and C) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7hrs; demoulding the prepared soft candy lozenges and stored in air tight container. The prepared soft candy lozenges are evaluated through factorial design, % drug content, in vitro drug release, friability, and stability study reveals the stability of the preparation and efficacy in oropharynx thrush.One of the preferred embodiments of the present invention is to optimized the metronidazole with novel process by converting it into soft candy lozenges with gelato-glycerin base in effective ratio 1: 3, 1: 4 and 1: 5 of gelatine to glycerinerespectively includes heating of gelatine from 12 to 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 to 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture of gelato-glycerin base. One of the preferred embodiments of the present invention is to prepare soft candy lozenges from triturating in clockwise manner, 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; then blending it with previously prepared gelato-glycerin base mixture with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7hrs; demoulding the prepared soft candy lozenges and stored in air tight containerOne of the preferred embodiments of the present invention is to evaluate prepared soft candy lozenges from factorial design, % drug content, in vitro drug release, friability, and stability study reveals the stability of the preparation and efficacy in oropharynx thrush.Brief Description of Drawings The following thorough explanation of the various aspects of the invention, taken in conjunction with the corresponding drawing that represents various aspects and other features of the disclosure invention. Figure 1: Flow chart of preparation process of soft candy metronidazole lozenges Figure 2: Formulation of optimized batchesFigure 3: % Cumulative drug release of F1 to F4 batches of formulationFigure 4: 3D surface plot; Pareto plot, and Box-cox plot (% drug release)Figure 5:3D surface plot in percentage, Pareto Plot and Box-cox plot (%friability) Figure 6: Statistical designs studied using First order, Zero order, Korsmeyer peppas model and Higuchi model.Detailed Description of the InventionThe following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration through explanation and figures for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the ingredients described without departing from the scope of the invention.The use of "including", "comprising" or "having" variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms "first", "second", and "third", and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.A Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof: A) Gelato-glycerin base: heating gelatine from 12 to 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 to 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture; B)Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; and C) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7hrs; demoulding the prepared soft candy lozenges and stored in air tight container. The prepared lozenges are evaluated through factorial design, % drug content, in vitro drug release, friability, and stability study reveals the stability of the preparation and efficacy in oropharynx thrush.Important steps involved in the preparation of lozenges formulationI) Gelato-glycerin base: Preparation gelato- glycerine base by heating gelatine with sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin with continuous stirring to obtain clear viscous solution; cooling the mixture and putting it on the magnetic stirrer for 1hr to form uniform mixture.II) Metronidazole Mix: Metronidazole Mix: triturating in clockwise manner metronidazole with of propylene glycol 400, methyl paraben and favoring agent in a sequential manner. III) Lozenges Formulation: Blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7 hrs; demoulding the prepared soft candy lozenges and stored in air tight container.Table No. 1: Formula of Chewable Metronidazole Soft Candy LozengesGeneral Formulation Process of soft candy lozenges FormulationA Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof: A) Gelato-glycerin base: heating gelatine from 12 to 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 to 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture;B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; andC) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7 hrs; demoulding the prepared soft candy lozenges and stored in air tight container. ( Table 1 & Figure 1) Example 1A Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3 of gelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof: A) Gelato-glycerin base: heating gelatine from 12 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture;B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; andC) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7 hrs; demoulding the prepared soft candy lozenges and stored in air tight container. ( Table 1 & Figure 1) Example 2A Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 4 ofgelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof:A) Gelato-glycerin base: heating gelatine from 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 60 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture;B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; and C) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7 hrs; demoulding the prepared soft candy lozenges and stored in air tight container. ( Table 1 & Figure 1)Example 3A Chewable Metronidazole Soft Candy Lozenges Preparation composed of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes the process to prepare thereof:A) Gelato-glycerin base: heating gelatine from 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture;B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; andC) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7 hrs; demoulding the prepared soft candy lozenges and stored in air tight container. ( Table 1 & Figure 1)MATERIALS AND TECHNIQUES: Metronidazole obtained as a kind gift sample from Blue cross Pharma, MIDC Ambad, Nashik. Gelatine, Methyl Paraben, Sucrose, Polyethylene glycol 400 and glycerin were purchased from Modern Industries, Nashik. Thermo Fisher Scientific India Pvt. Ltd. provided the analytical grade organic solvents and all other reagents utilized for assessment. Formulation of Chewable soft candy lozenges by using 22 Factorial Design.Metronidazole lozenges was developed using a 22 factorial design. There are two major product parameters- percent cumulative drug release and friability, Lozenges drug release property was used to find the optimum batch fromF1 to F4 (Table 2) using Design Expert software. After this the batch which was found to be optimized was selected for further process optimization. To this optimized batch two major process parameter - curing time and curing temperature was applying by using 22 factorial design to investigate how curing affects the formulation's percentage drug release. From this Gelatine and Glycerine were considered as dependent factors of product parameters optimization which are dependent on two independent variable that are % cumulative drug release, friability. A batches shown in Table 2 were created.Table 2: Formula for soft candy chewable lozenges developed by22 factorial designAnalysis of Optimization VariablesA 22 factorial technique was used to optimize the variables in this investigation. Stat-Ease 360, a design expert program, was used to develop the research plan and response surface plot and analyse data from all of the formulations. For each of the response variables, a general linear model was chosen using the program. The goal of a linear model is to use a group of categorical or quantitative independent variables to describe or predict a quantitatively dependent variable.Total Drug ContentTo determine the proportion of drug content in each created lozenges, the following procedure was used. Following the creation of the lozenges, 5 mL was collected and centrifuged at 1000 rpm for 15 minutes. After obtaining a 1 mL aliquot, diluting it with phosphate buffer pH 6.8, and filtering it, the drug concentration of the diluted sample was determined using a UV spectrophotometer at λ max 275 nm15. …2In vitro drug release studiesPhosphate buffer saline (PBS), pH 6.8 is used as the dissolving solvent at 37 ± 0.5 °C and an Electrolab Dissolution Tester USP EDT 08L, a USP class II dissolution equipment, spinning at a speed of 100 rpm. The research examined thetrends of medicine release. A specimen (5 ml) had been collected at various times, ranging from 10 to 90 minutes. A fresh dissolving medium was added with the same volume. Using a Shimadzu UV1800 spectrophotometer, the quantity of Metronidazole that was liberated was assessed at Amax 275 nm (n = 2).RESULTS AND DISCUSSION % Total Drug ContentThe range of 80.76±0.66 to 98.84±0.55%, respectively, was found for the final batches of lozenges total medication content, indicating minimal drug loss during the formulation process. Batch F2 shows highest yields percentage of total medication (98.84±0.55%)18. Dissolution Profile of Soft Candy Chewable Lozenges:Drug release of all the F1 to F4 Batches with variable concentration of Gelatine & glycerin was studied and it was found that F1, F3, F4 batches shows 100 % drug release in more than 100 minutes. But the F2 batch shows 100.82 % drug release up to 88 minutes, which was selected as optimized batch due to its proper fast release effect of drug with 15gm of Gelatine concentration and Glycerin with 65mL concentration.Optimization Data AnalysisProcess parameter of optimizationTable 3. Formulation batch optimized by applying 22 factorial design to process parameterThe optimization was done using a 22 technique. Utilizing Design Expert Stat-Ease360, data from every formulation was examined. Two elements were employed in this case: % Drug Release (Y1) and Friability (Y2) are the responses 1 and 2, while Gelatine (X1) and Glycerine (X2) are the factors A and B. Additionally, two levels-low and high-were chosen. The Stat-Ease 360 program was used to evaluate and improve the statistics from each formulation. For optimization, a linear model was mostly employed. To complete the optimization process, two dependent factors (Y1, Y2) as well as two independent components (X1, X2) were taken into consideration as factors and responses, respectively. Two factors were considered: Gelatine (mg) (X1), and glycerine (mL) (X2). These values were low and high. Factor 1 with the concentration of Gelatine for all four batches was selected as a continuous factor, whereas the concentration of glycerine for each of the four batches was selected as a discrete factor. The statistical result, which included validation of the batch that was optimized, was obtained by analysis. It was discovered that the F2 batch was optimized.ANOVA for Linear ModelResponse 1: %Drug releaseSince green hues exist in equal numbers in the 3D surface plot (Figure 3) demonstrate that the effects of gelatine and glycerine on drug release are identical. Furthermore, the pareto plot showed an interaction appearance between the two lines, suggesting that gelatine had more impact on drug release. In this case, desirability-which emerged to comply with the essential requirement and assisted in determining the study's appropriate formulation-should be less than or equal to 1.Response 2: %FriabilityGreen was more noticeable in the 3D surface plot (Figure 4), suggesting that glycerine has a higher effect on the percentage of friability than gelatine. Further evidence that glycerine had a stronger effect on %friability than gelatine came from the pareto plot, where the blue line representing Factor A, or gelatine,showed less interaction behaviour than the orange line representing Factor B, or glycerine.Stability studyTable 4. Results of stability test of optimum (F2) batchStatistical design:For the kinetic best-fit model study, MS Excel 2003 was used. Various model- based plots like zero-order, Higuchi, korsmeyer peppas and first order model were determined by calculating required values through the % cumulative drug release. From these plots, the R2 (coefficient of regression) and n (slope) values were obtained. R2 is a metric for a model's efficiency of matching up. The R2 coefficient is a quantitative tool to find how closely regression projections resemble actual observed values in regression. The regression projections exactly match the dataset with an R2 equal to 1. According to this, With R2 values is 0.9165 and 0.9833, respectively, the zero-order and Higuchi models were determined to be the best fit models for the optimized (F2) batch. (Figure 4). The zero-order profile indicates that the formulation shows controlled release of medicament over a prolonged period.CONCLUSIONFast-acting chewable lozenges were successfully prepared using the heating and congealing method with Gelato-glycerine base, demonstrating approximately100.82% drug release over 90 minutes. Drug release behaviour was influenced by variations in gelling excipient quantity, heating, and cooling conditions, highlighting their critical role in formulation efficacy. Lozenges formulated with Gelatine (15g) and Glycerine (65mL) were identified as optimal based on drug release, friability, and stability parameters after three months at 25°C and 75% relative humidity during expedited storage. The final optimized batch (F2) maintained stable drug release and content, suggesting potential improvements in patient compliance and dosing frequency.Scope of the InventionThe present invention relates novel chewable metronidazole soft candy lozenges preparation composed of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives of propylene glycol, methyl paraben and flavoring agent to form soft candy lozenges, evaluated through factorial design, % drug content, in vitro drug release, friability, and stability study reveals the stability of the preparation and efficacy in oropharynx thrush, could be a promising new form metronidazole dosage form for better therapeutic effects in future, compare to existing formulations.It is to be understood that the present invention is not limited to the embodiments described above, it should be clear that various modifications and alterations can be made along with various features of one embodiment included in other embodiments, within the scope of the present invention.

Claims

1. A process to prepare chewable metronidazole soft candy lozenges comprises of 0.25 gm of metronidazole taken with gelato-glycerine base in effective ratio of 1: 3, 1: 4 and 1: 5 of gelatine to glycerine respectively with additives to form soft candy lozenges includes following steps: A) Gelato-glycerin base: heating gelatine from 12 to 15 % w / w with 5% w / w sucrose syrup in hot water bath with continuous stirring; adding to it, glycerin from 35 to 75 % v / v with continuous stirring at temperature 150°-160°C to obtain clear viscous solution; cooling the mixture up to 80°- 90°C and putting it on the magnetic stirrer for 1hr at 100°C; again cooling it from 60°- 70°C to room temperature to form uniform mixture; B) Metronidazole Mix: triturating in clockwise manner 0.25 gm of metronidazole with 2% v / v of propylene glycol 400, 3% w / w methyl paraben and favoring agent in a sequential manner; and C) Lozenges Blend: blending gelato-glycerin base mixture (A) with metronidazole mix (B) with continuous stirring at a temperature from 50°- 60°C to get uniform mixture; immediately pouring it during hot into previously greased mould; setting the solution and keeping it in refrigerator for 6-7hrs; demoulding the prepared soft candy lozenges and stored in air tight container.

2. The chewable metronidazole soft candy lozenges as claimed in claim 1, wherein the total drug content of metronidazole is from 80.76 ± 0.66 to 98.84 ± 0.55 %.

3. The chewable metronidazole soft candy lozenges as claimed in claim 1, wherein the drug release is from 86.02 to 104. 75 %.