Formulation and evaluation of herbal tablet for dysmenorrhoea

1. “ FORMULATION AND EVALUATION OF HERBAL TABLET FOR DYSMENORRHEA ” Prepared by - Ashish Kalse

2. Content ● Introduction ● Advantages ● Objectives ● Material and Drug Profile ● Method of Formulation ● Pre formulation study ● Evaluation Parameters ● Result and Discussion ● Conclusion

3. INTRODUCTION ● Dysmenorrhea, also known as dysmenorrhoea, painful periods, or menstrual cramps, it is pain during menstruation. ● Dysmenorrhea is a term describing painful menstruation that typically involves cramps caused by uterine contractions. ● Dysmenorrhea is divided into two categories: 1. Primary dysmenorrhea 2. Secondary dysmenorrhea

4. Primary Dysmenorrhea Painful menstruation with no pelvic pathology. The highest level is in the first 2 days of menses. Causes :- Increased prostaglandin production by the endometrium in an ovulatory cycle which cause contraction of the uterus.

5. Secondary Dysmenorrhea Painful menstruation due to pelvic or uterine pathology. Causes:- Endometriosis Adenomyosis Pelvic infection

6. Why are we choose this topic ? Indian Pharmacopoeia Commission (IPC) recently issued a drug safety alert for Mefenamic acid and urged both consumers and healthcare professionals to exercise heightened vigilance concerning the potential adverse drug reaction (ADR) linked to Meftal spas medication, which is often prescribed for conditions such as menstrual cramps and rheumatoid arthritis. According to experts, it can cause an adverse reaction that includes Eosinophilia and Systemic Symptoms (DRESS) syndrome.

7. ADVANTAGES ● Low risk of side effect. ● More effectiveness. ● Lower cost. ● Herbal tablets can be used for a wide range of health issues, including digestive problems, stress, insomnia, and immune support. ● Herbal tablets in traditional medicine systems aim to treat the root cause of health problems, not just the symptoms.

8. OBJECTIVES ● The herbal tablets for dysmenorrhea is to provide natural relief from menstrual cramps and discomfort associated with menstruation. ● Herbal tablets may contain ingredients such as ginger, cinnamon, fennel and others that have anti-inflammatory and pain-relieving properties to help alleviate menstrual pain.

9. SR.NO CRUDE DRUG PROPERTIES 1 Cinnamon Anti inflammatory 2 Ginger Anti inflammatory MATERIAL 3 Mentha Anti-inflammatory 4 Fennel Antioxidant 5 Tulsi Analgesic SR. NO. EXCIPIENTS PROPERTIES 1 Lactose Binder 2 Starch Disintegrant 3 Magnesium stearate Lubricant

10. DRUG PROFILE 1.Ginger :- Ginger is obtained from the rhizome (underground stem) of the plant Zingiber officinale. Family:- Zingiberaceae Chemical constituents:- gingerol, shogaol, paradol, zingerone. Ginger contains compounds anti-inflammatory effects, which may benefit conditions such as arthritis and muscle pain. ? ? ? ? that exhibit

11. 2. Cinnamon :- Cinnamon is obtained from the inner bark of trees belonging to the genus Cinnamomum. ? ? Family:- Lauraceae ? ? Chemical constituents:- cinnamaldehyde, cinnamate, cinnamic acid. Cinnamon has been traditionally used for its anti-inflammatory effects, which may help in conditions such as arthritis and inflammatory disorders.

12. 3. Mentha :- It is obtained from the fresh leaves of Mentha piperita . Family :- Lamiaceae Chemical constituents :- Menthol , Menthone , Limonene , Caryophyllene . ? ? ? ? Mentha contains compounds that exhibit antioxidant activity, which can help protect cells from oxidative damage. Mentha is commonly used to relieve indigestion, bloating, gas, and gastrointestinal discomfort.

13. 4. Fennel :- Fennel is derived from the flowering plant species Foeniculum vulgare. ? ? Family :- Apiaceae ? ? Chemical constituents :- Anethole, Fenchone, Estragole, Limonene. Fennel has been traditionally used to help regulate menstrual cycles and reduce menstrual cramps.

14. 5. Tulsi :- Tulsi is derived from the plant species Ocimum sanctum. ? ? Family:- Lamiaceae ? ? Chemical constituents:- : Eugenol ,Rosmarinic acid, Ursolic acid. Tulsi contains compounds that exhibit anti-inflammatory properties, which may help reduce inflammation in the body. Tulsi has antimicrobial properties and is used to combat infections caused by bacteria, viruses, and fungi.

15. Method of formulation ● All the required powdered mixtures were precisely weighted and were passed through a standard sieve (sieve no. 80) and blended for 5 min. ● Then the mixed powders were converted into granules by using wet granulation method. ● The granules were evaluated for pre evaluation parameters like tapped density, bulk density, Hausner’s ratio, angle of repose and compressibility index (Carr’s index). ● Herbal tablets were prepared by compression method using single punch tablet press machine , batches (F1, F2) of yellowish-brown tablets with an average mass of 500 mg were obtained. ● The post evaluation parameters were performed for the formulation that i.e. Weight variation test, hardness test, friability testing, disintegration test.

16. Table 1 : Composition Of Herbal Tablet ( 500mg) Sr.no. Ingredient used Quantity taken 1 Fennel 200mg 2 Cinnamon 30mg 3 Ginger 90mg 4 Mentha 15mg 5 Tulsi 5mg 6 Lactose 100mg 7 Starch 55mg 8 Mg.sterate 5mg

17. PRE FORMULATION STUDY ● Pre-compression Parameters: 1. Bulk Density:- Measures mass of powder in a known volume. Bulk density = M/Vb Where, M is given as the mass of the sample, Vb as the bulk Volume. 2. Tapped Density:- Density of powder after tapping, indicating packing characteristics. Tapped density = weight of powder blend/Minimum volume of the cylinder. 3. Hausner’s Ratio:- Tapped density divided by bulk density, indicating flowability. Hausner’s ratio = Tapped density/ Bulk density 4. Carr’s Index:- Compressibility index calculated from bulk and tapped densities. . Carr’s index = Tapped density-Bulk density × 100/ Tapped Density 5. Angle of Repose:- Maximum angle of a powder pile without sliding, indicating flowability. tan θ = h / r. Where r is the redius , h is height of pile.

18. EVALUATION PARAMETERS 1. Tablet Dimensions :- Ten tablets were selected from each formulation and were evaluated for thickness and diameter using a Calibrated dial caliper. 2. Weight Variation test :- Twenty tablets were selected randomly from the formulation. Tablets were weighed one by one and then the Average weight was calculated. Deviation of each tablet from average weight was calculated and then the percent deviation was computed. 3. Tablet Hardness :- The hardness was being evaluated by using Monsanto hardness tester.

19. 4. Friability Test :- It is carried out, using Friability apparatus. The weighted tablets are being placed in the apparatus and which is been rotated at 25 rpm for 4 minutes. After an interval tablets are taken out from apparatus and Once again they are weight. The friability is calculated by given formula. Friability = Initial weight - Final weight /Initial weight *100 5. Disintegration Test :- 6 tablets were taken for the estimation of the disintegration time. The tablets were placed in the disintegration Apparatus and then the time was observed until the tablet were totally disintegrated. The temperature for the Apparatus was maintained at 37º C.

20. Result & Discussion Sr no Ingredients F 1 F 2 1 Fennel 200mg 150mg Formulation of herbal tablet with crude drugs :- two batches of tablet were prepared containing the crude drugs like fennel, cinnamon, mentha, ginger, tulsi, etc. These are the main ingredients that are used for the manufacturing of F1 and F2 batches that are showed in the Table no. 2 2 Cinnamon 30mg 10mg 3 Ginger 90mg 35mg 4 Mentha 15mg 50mg 5 Tulsi 5mg 50mg 6 Lactose 100mg 100mg 7 Starch 55mg 100mg 8 Mg. stearate 5mg 5mg Table 2 : Composition of different batches of herbal tablet

21. Evaluation of Granules :- ●The evaluation parameters , angle of repose, tapped density, bulk density, Carr’s Index and Hausner’s Ratio were carried out for the granules that are showed in the Table No.3. Table 3. Evaluation Parameters of granules Sr. no . Evaluation Parameters F1 F2 1 Angle of Repose (°) 43.75 42.80 2 Tapped density (gm/ml) 0.57 0.55 3 Bulk density (gm/ml) 0.20 0.22 4 Carr’s index (%) 64.99 64.50 5 Hausner ‘s ratio 2.85 2.45

22. Evaluation of Tablet :- ▪ ▪ The evaluation parameters like Physical appearance, weight variation, friability, hardness, thicknes and disintegration test were carried for the batches and some of them are shown in Table no.4 Table 4 . Evaluation Parameters of Tablet Sr. No. Evaluation parameters F1 F2 1 Thickness ( mm) 6 5.8 2 Hardness ( kg/cm2) 5 7 3 % weight variation 3.7 4 4 Friability (%) 4.3 2.7

23. Conclusion we have discussed the importance of herbal tablets in managing dysmenorrhea, highlighting their potential benefits in providing relief from menstrual cramps and other symptoms associated with this condition. Herbal tablets offer a natural alternative to traditional pain medications, with fewer potential side effects. Encouraging further exploration and development in herbal medicine can lead to the discovery of more effective treatments for dysmenorrhea and other health conditions, expanding healthcare options for those seeking natural remedies. From the above study, we conclude that the herbal tablets were prepared by wet granulation method and which gave the satisfactory and acceptable result.

24. Thank you