004-Korde Aditya Project A22.pptx gor notes

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At - Bangarwadi Po–Belhe Tal–Junnar , Dist -Pune 412410 2023-24 “ Formulation and evaluation of Gargles Using Marshmallow Root Powder ” SAMARTH INSTITUTE OF PHARMACY Samarth Rural educational Institute’s Rajuri’s PRESENTED BY :- Mr. Korde .Aditya B. PHARM Final YEAR Roll no. :- 004 UNDER THE GUIDANCE :- Dr. Wakale V S (M. Pharm, PhD)

Introduction Aim & Objective Literature Review Plant Profile Materials And Methods Evaluation of Gargles Result and Discussion Conclusion References CONTENT

Abstract Gargles are aqueous solutions used to treat or prevent infections of the throat and mouth. Marshmallow (Althaea officinalis L.) is a medicinal plant that has been traditionally used for its anti-inflammatory, demulcent, and soothing properties on the mucous membranes. The aim of this study was to prepare and evaluate gargles containing marshmallow roots extracted powder as an active ingredient . The powder was obtained by drying and grinding the roots of marshmallow. The gargles were formulated with different concentrations of the powder and various excipients such as glycerin, sodium benzoate, citric acid, and peppermint oil. The gargles were characterized for their physicochemical properties , such as pH, viscosity, density, and microbial contamination. Keywords : Gargles ,Marshmallow (Althaea officinalis L.), Antitussives , Herbal medicine , Throat infection .

ABSTRACT Gargles are aqueous solutions used to treat or prevent infections of the throat and mouth. Marshmallow ( Althaea officinalis L .) is a medicinal plant that has been traditionally used for its anti-inflammatory, demulcent, and soothing properties on the mucous membranes. The aim of this study was to Formulate and evaluate gargles containing marshmallow roots extracted powder as an active ingredient. The powder was obtained by drying and grinding the roots of marshmallow. The gargles were formulated with different concentrations of the powder and various excipients. The gargles were characterized for their physicochemical properties, such as pH, viscosity, density, anti- microbial contamination. Keywords: Gargles, Marshmallow ( Althaea officinalis L .) , Antitussives , Sore throat , Throat infection.

Introduction Cough is one of the most common symptoms that affects millions of people worldwide. It can be caused by various factors, such as respiratory infections, allergies, asthma, chronic obstructive pulmonary disease, gastroesophageal reflux disease, and environmental irritants. Cough can have negative impacts on physical, psychological, and social aspects of life, such as pain, fatigue, sleep disturbance, anxiety, depression, and social isolation. Therefore, effective and safe management of cough is essential for improving the health and well-being of patients and the general population. One of the most popular and widely used natural remedies is gargling with salt water or other solutions. Gargling is believed to have several benefits, such as soothing the throat, reducing inflammation, loosening mucus, and killing bacteria. Gargling is also considered as a simple and traditional remedy for cough in many cultures. Various ingredients, such as herbs, spices, vinegar, and lemon, are added to the gargling solutions to enhance their effects. Some of these ingredients have been used for centuries in traditional medicine systems, such as Ayurveda, Chinese medicine, and Unani medicine. Gargles are solutions that are swished or gargled in the mouth and throat to soothe the irritated mucosa and reduce inflammation.

Aim and objectives Objective : To formulate gargles with different concentrations of marshmallow roots powder and various excipients. To carry out Preformulation study of Marshmallow Root Powder Physicochemical properties Phytochemical analysis To carry out Post formulation study of Gargles pH Viscosity Density Palatability Microbial contamination Draw conclusions regarding the effectiveness of, Marshmallow (Althaea officinalis L.) as a potential therapeutic agent against sore throat and cough Aim : To formulate and evaluate herbal gargles from marshmallow roots powder.

Literature reviews Sr . No. Activity Name of Author 1. Review on comphrehensive use of marshmallow roots powder against cough Careen Fink et al; 2018 2. A review on pharmacological and phytochemical profile of ( Althaea officinalis) Mazhar Husain et al; 2021 3. Research article on preparation of lozenges using Marshmallow roots powder extract gives a study on benefits and validation of herbal root powder for formulation Niko Benbassat et al; 2013 4 A review on different formulations to cobat against sore throats including different formulations of expectorants Seema Gairola et al;2010

Sr . No. Activity Name of Authors 5 A review on Therapeutic effects of marshmallow (Althaea officinalis L.) Mahdi Banee et al;2017 6 A review on Evaluation of the Bactericidal Activity of PovidoneIodine and Commercially Available Gargle Preparations Tadashi Shiraishi et al;2002 7. Reviewed work on plant information of Althaea officinalis Oxana Vronskaya et al; 2021 8 A review on Antibacterial Activity of the Herbal Gargles gives a data on antibacterial activity of gargles & there formulation  Saraladevi V et al;2019

Plant Profile (Althaea officinalis L.) Plant Descirption Roots Thick, long, tapering, and white, with a mucilaginous and sweet taste Synonyms Malva officinalis , A. taurinensis DC., Althaea kragujevacensis , Althaea micrantha , Althaea sublobata , Althaea vulgaris, Malva althaea , Malva maritima , BiologicalSource It s a dried roots which is obtained by Althaea officinalis L. Belonging to the family Malvaceae ScientificName . Althaea officinalis L CommonName marshmallow, marsh mallow, white mallow, hollyhock, cheeses, mortification root, sweet weed, and wymote. In India, it is known as Khatmi, Shemai-tutti, Aslua Khitmi, or Reshah-e-Khatmi Origin This plant is indigenous to Europe, Western Asia and North Africa. It is a perennial herb that grows in marshy areas

Taxonomical classification Taxonomical Classification : Kingdom Plantae Subkingdom Plantae SuperDivision Spermatophyta Division Magnoliophyta Class Magnoliopsida Subclass Magnoliopsida Order Magoliales Family Malvaceae Genus Althaea officinalis Species Althaea officinalis

Plan of present Work Content Literature Review Collection and identification of marshmallow root Prototype Formulation Development Preformulation study of Marshmallow Root Powder Preparation of gargles Post formulation study of Gargles

Material and Method

Material and Method Selection of Plant- In this present study, I have selected the Althaea officinalis L. Collection of Root powder- The root powder i.e. Althaea officinalis L. ( Malvaceae ) were collected from the Elite global services 1575, Pataudi house New Delhi, during the month of January in the year 2024. The fresh crude drug obtained was shade dried, coarsely powdered, passed through 44 mesh sieve and stored in an air - tight containers. Fig. Marshmallow Root Powder ( Althaea officinalis Linn)

Certificate of Analysis

Preformulation study of Marshmallow Root Powder Preformulation studies are critical in the development of pharmaceutical formulations, providing essential data on the physical and chemical properties of the active ingredient. Physiochemical Properties Misture Content Particle Size Bulk Density Solubility PH

2.Phytochemical Analysis 1.Organoleptic Evaluation Apperance Odor Taste 2.Preliminary Taste Test for Polysaccharide(Iodine Test) Test for Saponin Test for flavonoids(Lead Acetate Test) Test for Carbohydrate ( Molisch Test) Test for Phenols ( Feric Choride Test) Test for Mucilage(Alcohol Test)

Sr.No . Excipient Role 1. Marshmallow Root Powder Active ingredient 2. Purified Water Base for the gargle solution 3. Sodium Bicarbonate Buffer solution 4. Hydroxyethyl Cellulose Enhancing the physical stability 5. Lemon Juice Flavor 7. Food-Grade Coloring Adds visual appeal 8. Potassium Sorbate Shelf-life improver 9. EDTA Minimize viscosity Excipient Profile:

Sr. No. Excipient Quantity (ml) Role F1 F2 F3 F4 1. Marshmallow Root Powder 1.5 1.5 1.5 1.5 Active ingredient 2. Purified Water 24.85 23.05 20.25 22.25 Base for the gargle solution 3. Sodium Bicarbonate 0.6 1 1 0.6 Buffer solution 4. Hydroxy Ethyl Cellulose 0.4 0.8 1.5 1 Enhancing the physical stability 5. Lemon Juice 1 1.5 2 2 Flavor 7. Food-Grade Coloring 1 1 1 1 Adds visual appeal 8. Potassium Sorbate 0.15 0.15 0.15 0.15 Shelf-life improver 9. EDTA 0.5 1 2 1.5 Minimize viscosity Formulation of Gargles 30 ml Using Marshmallow Root Powder:

Procedure for Formulation of Gargles 30 ml Using Marshmallow Root Powder 5 % w/v Solution: 1. Sieve the marshmallow root powder through a mesh size of 44. 2. Weigh out 1.5 grams of the sieved powder using a measuring balance. 3. Add the powder to 22.45 ml of distilled water. 4. Stir the mixture in warm water until it is well combined. 5. Allow the mixture to cool down to room temperature. 6. Withdraw a 1.5 ml sample of the solution. 7. Transfer the sample into a separate 250 ml beaker. 8. Add all the required excipients to the beaker. 9. Stir the solution for two minutes to ensure thorough mixing. Fig. Magnetic Stirrer 10. Place the beaker on a magnetic stirrer. 11. Turn on the magnetic stirrer to the desired revolutions per minute (rpm). Ensure that no heat is applied. 12. Stir the solution for four hours. 13. Fill the stirred solution into a sterilized container. 14. Seal the container with a cap to ensure it is airtight. 15. Store the sealed container in a cool and dry place away from direct sunlight. 16.Please ensure that all equipment used in this procedure is properly sterilized before use to maintain the solution's integrity.  

Post Formulation Study of Gargles Parameters Palatability Studies Stability Studies pH Viscosity Density Anti-Microbial Test

Result And Discussion Sr no. Parameters Observations   Moisture content 3.07%   Particle Size 300 μm   Bulk Density 5 %   Solubility Soluble in Warm Water   pH 5.92 Following evaluation parameters were performed for quality evaluation of ( Althaea officinalis L. ) 1 Preformulation study of Marshmallow Root Powder: 1.1 Physicochemical properties: Table no. 1

Sr. No. Parameters Observations   Polysaccharides Positive   Saponin Positive   Flavonoids Positive   Carbohydrate Positive   Phenols Positive   Mucilage Positive 1.2 Phytochemical analysis: Table no.1.2

Sr No. Parameters At room Temperature   Color No change   Odor No change   pH 5.54 2. Post formulation study of Gargles 2.1 Palatability Study The results of Palatability were shown in Table. No change in color, odor, texture was observed. The palatability studies showed a slight change in pH of formulation at 40 C. Table no.2.1 Palatability Test

Sr No. Parameters At room Temperature At 40 C 1 Color No change No change 2 Odor No change No change 3 Texture Fine Fine 4 pH 6.82 6.78 2.2 Stability Studies: The results of stability were shown in Table. No change in color, odor, texture and smoothness was observed. The stability studies showed a slight change in pH of formulation at 40 C. Table no. 2.2 - Stability Test

Sr No. Parameters Results F1 F2 F3 F4   pH 7.6 6.2 5.4 5.9   Viscosity 80mPa 68mPa 60mPa 56mPa   Density 6 5.8 5.8 5.4   Anti-Microbial test (Zone of inhibition) - - - 36mm 2.3 Evaluation Parameters for post formulation study of Gargles Table no.2.3 Post formulation study Fig. pH Meter Fig. Brook Field Viscometer

Sr. No. Bacteria Zone of inhibition (in mm) 1 Escherichia coli 36mm 2.4 Anti-Microbial Assay: The antibacterial activities were evaluated by measuring the zones of inhibition (in mm). The results of evaluation are shown in Table 2.4. Table no.2.4 Anti-microbial Assay Before keeping in incubator Zone of inhibition shown by Escherichia coli a) b)

CONCLUSION The formulation and evaluation of gargles using marshmallow root powder (Althaea officinalis ) have demonstrated promising results. The phytochemical properties of marshmallow root, known for its mucilaginous and soothing effects, make it an excellent candidate for gargle formulations aimed at relieving throat discomfort. The evaluation process included assessing the palatability, ensuring the stability of the gargle solution and verifying the antimicrobial efficacy, which is crucial for a product intended to alleviate throat infections. The formulation was optimized for concentration, resulting in a gargle solution that is both effective and pleasant to use.

SUMMARY Marshmallow root powder is utilized for its mucilaginous properties, which form a soothing layer on the throat, potentially easing irritation and cough. The preparation involves infusing the powder in cold water, which is then used as a gargle solution. Evaluation of the gargle has shown it to be effective in providing rapid relief from throat discomfort and dry cough, often within minutes of use. The natural constituents of marshmallow root make it a safe and well-tolerated option for symptomatic relief of sore throat and cough.

Reference Finkelstein JA, Christiansen CL, Platt R. Fever in pediatric primary care: occurrence, management, and outcomes. Pediatrics. 2000;105( Suppl 2):260–6. Ahmad, L. (2021). Impact of gargling on respiratory infections.  All Life ,  14 (1), 147–158. . Hughes DTD, Todays Treatment, Disease of the Respiratory System Cough Suppressants, expectorant and mucolytics , British Medical Journal, 1, 1978, 1202-1203. Shah SA, Akhtar N, Akram M, Shah PA, Saeed T, Ahmed K, Asif HM. Pharmacological activity of Althaea officinalis L . Journal of Medicinal Plants Research 2011 Oct 30; 5(24): 5662-6. Deters, A., Zippel , J., Hellenbrand , N., Pappai , D., Possemeyer , C., & Hensel , A. (2010). Aqueous extracts and polysaccharides from Marshmallow roots (Althea officinalis L.): Cellular internalization and stimulation of cell physiology of human epithelial cells in vitro.  Journal of Ethnopharmacology ,  127 (1), 62–69. Fink, C., Schmidt, M., & Kraft, K. (2018). Marshmallow root extract for the treatment of irritative cough: Two surveys on users’ view on effectiveness and tolerability.  Complementary Medicine Research ,  25 (5), 299–305.

Wink, M. (2015). Modes of action of herbal medicines and plant secondary metabolites.  Medicines ,  2 (3), 251–286 Mazhar Husain 1, M. Zaigham 2, Hamid Uddin 2 *, Abdul Wadud 1, Mohd . Akhtar Ali A review on pharmacological and phytochemical profile of Khatami ( Althaea officinalis l inn .): an important mucilaginous plant and its utilization in Unani system of medicine ijrap 2021 p. 166-169. Gautam , S., Navneet , N., Kumar, S., & Chauhan , R. (2015). Antimicrobial efficacy of Althaea officinalis Linn. seed extracts and essential oil against respiratory tract pathogens.  Journal of Applied Pharmaceutical Science , 115–119 Palombo , E. A. (2011). Traditional Medicinal Plant Extracts and Natural Products with Activity against Oral Bacteria: Potential Application in the Prevention and Treatment of Oral Diseases.  Evidence-based Complementary and Alternative Medicine ,  2011 , 1–15.  Benbassat , N., Kostova , B., Nikolova , I., & Rachev , D. (2013). Development and evaluation of novel lozenges containing marshmallow root extract.  PubMed ,  26 (6), 1103–1107.  Choudhary , A. (2024, April 17).  Definition and preparation of gargles, mouthwash andthroat paint . Pharma guideline.