Formulation and Evaluation of Effervescent Tablets Using Natural Excipients: A Non-Aqueous Wet Granulation Approach

Abstract

Effervescent tablets and granules are special dosage forms that contain a medicine plus an effervescent base made of citric acid, tartaric acid, and sodium hydrogen carbonate. When these substances are added to water, they react to release carbon dioxide, which causes effervescence. There are many uses for these granules in daily life. Information on the different ingredients used to make effervescent granules and tablets is provided in this review. Numerous techniques, including the wet method, dry method, fusion method, hot-melt extrusion method, and non-aqueous method, can be used to create effervescent granules. Compression, dry granulation, and wet granulation are methods for creating effervescent pills

Keywords

Introduction

METHODOLOGY

Figure 6.1: Types of wet granulation

Organic solvents are used in the non-aqueous granulation process. Certain molecules are not suitable for dry mixing because they are temperature and moisture sensitive. These medications often make up a large portion of the formulation, which is made via non-aqueous granulation with organic solvents such as dichloromethane, chloroform, and isopropyl alcohol as a binder solution. Throughout this procedure, safety is crucial, thus all equipment must be flameproof, located in a designated location, and equipped with all necessary safety precautions.
Preparation Of Excipients-

Figure 1 : Preparation Of Okra Mucilage Powder

1. Purchase 250g of fresh pods of okra (Abelmoschus esculentus) at the neighborhood store.
2. The gathered okra was meticulously cleaned and sliced into tiny, 5 mm pieces.
3. After that, dry the tiny okra pieces in a hot air oven set at 70°C for 30 minutes, or until their weight remained consistent.
4. Use a mortar and pestle to cool it and minimize its size.
5. The powdered okra pods were placed in an airtight container for later usage after passing through filter number 22.

Figure 2: Extraction Of Mucilage

Step 2: Mucilage Isolation:
1. In 250 milliliters of ethanol, the extracted gum has separated.
2. This makes it possible to filter through muslin material.
3. Filtered through muslin cloth and washed with ethanol.
4. In a hot air oven, the pressed mucilage was further dried to constant weight for 15 minutes at 35–40°C.
5. To create a fine powder of dried okra mucilage extract, hard mucilage cake was ground with a mortar and pestle.
6. After that, it was sieved using sieve number 22.

Figure 3: Isolation Of Okra Powder

Preparation Of Banana Powder-

Figure 4: Preparation Of Banana Powder

1. Gather two to three mature, medium-sized raw banana bunches. 2. The raw banana that was collected was meticulously cleaned and dried.
3. Sliced into thin pieces after peeling.
4. In a hot air oven, dry the banana slices for one hour at 100°C. until the weight remains constant was acquired.
5. Use a mortar and pestle to cool it and minimize its size.
6. The powdered raw banana powder was kept in an airtight container for later usage after passing through sieve number 50.

Figure 5: Preparation of Effervescent Granules

Binder preparation:

1. 5 milliliters of ethanol. As a binder, mix in some okra mucilage powder. After thorough mixing, a binding solution is created.
2. Include the okra mucilage binding solution in a powder combination.
3. Thoroughly mix it until a wet mixture forms.
4. To get granules, the resulting mixture was sieved using sieve no. 8#.
5. In a hot air oven, granules were dried for 30 minutes at 40°C.
6. The dried granules were kept above sieve no. 20# after passing through sieve no. 14#.
7. The item came in a sachet.

Preparation Of Effervescent Tablets

Stage I: The dies are filled with powdered grains.
Step 1: Allow the lower punch to descend to its lowest position.
Step 2: Powder is fully poured into the die's bore.
Step 3: To ensure excess, the lower punch is elevated to the predetermined point. Step 4: Level the powder by passing it beneath the blade.
Step 5: This guarantees that the die's bore is filled with a precise the next step and the volume of the powder or granules to be used.

Stage II: The bed of powder or grains is compressed.
Step 6: Lower the upper punch into the die's bore.
Step 7: Precompression provides a first blow to the powder to eliminate extra air.
Step 8: Complete compression of the powder. Step 9: The right amount of pressure is applied.
The tenth step involves moving the upper punch upward.

Stage III: Ejection of the tablet.
Step 11: Until the next step is reached, the bottom punch starts to rise into the die raising tablet's bore.
Step 12: The foundation level with the die on top
Step 13: The tablet is passed beneath a static blade and punched aside into the take-off chute.

Step 14: The lower punch is prepared for filling by moving to its lowest position on the die.
Step 15: Complete the punching cycle again.

Evaluation & Results:

The evaluation table indicates that F5 was effectively developed.
The following are
F5 batch evaluation test: -

1. Thickness: 1.33 mm
2. Hardness: 1.2 kg/cm
3. Variation in weight: pass
4. Uniformity of content: -100.23
5. Friability: less than 1%
6. Disintegration: 1 min 5 sec
7. Time of effort: 50 sec
   For a number of test characteristics, including weight fluctuation, hardness, friability, thickness, and content homogeneity, the F5 batch of effervescent tablets demonstrated considerable and acceptable tablet as a limits that complied with official IP specifications.

Organoleptic properties-

Colour- White

Taste- Sour

Appearance- Smooth

Shape- Standard convex

CONCLUSION:

It was determined that the effervescent reaction of citric acid, tartaric acid, and sodium bicarbonate provides superior effervescence, and that the effervescent tablet of aspirin can be prepared for rapid analgesic, antipyretic, and anti-inflammatory effect. Complementary excipients can only be utilized for formulation development, according to our review of the literature. Compared to a single unit dosage form, the gastro-intestinal tract (GIT) and delayed release of aspirin may lead to more consistent drug absorption and lower the risk of local discomfort. The non-aqueous wet granulation process produced effervescent tablets that demonstrated satisfactory results in terms of post-formulation assessment criteria. According to the results of the entire investigation, aspirin was effectively prepared and assessed as effervescent tablets utilizing a non-aqueous granulation process in conjunction with powdered banana and okra mucilage. It appears to be a promising formulation for the safe and efficient administration of medication.

REFERENCES

1. 1. 1. 1. R. B. Jadhav, D. S. Sonwane, S. J. Surana, Crypto protective effect of crude polysaccharides fraction of Abelmoschus Esculentes fruits in rats. Pharmacognosy magazine. 2008; 4(15): 130-132.
         2. Jinan Al- Mousawy, Zahraa Al- Hussainy, Maryam Alaayedi. Formulation and evaluation of effervescent granules of ibuprofen. International journal of applied pharmaceutics. 2019; 11(6): 66-69
         3. A. Salomy Monica diyya, Noel Vinay Thomas. Formulation and evaluation ofmetronidazole effervescent granules. International journal of pharmaceutical scienceand research. 2018; 9(6): 2525-2529.
         4. Pratibha Kale. Extraction and characterization of okra mucilage in pharmaceutical aid. International Journal of scientific development and Research. 2020; 5(4): 189-193.
         5. Biswajit Biswal, Naveen Karna, Rashimika Patel. Okra mucilage act as a potential binder for the preparation of tablet formulation. Scholars research library. 2014; 6(3): 31-39.
         6. R.B. Saudagar. Formulation, Characterization and evaluation of mouth dissolving tablets of Lisinopril by using dehydrated banana powder as a natural polymer. World journal of pharmaceutical research. 2015; 4(12): 763-774.
         7. Ina Ba’diaGrajang and IisWahyuningsih. Formulation of Sechium edule Extract Effervescent Granule with the Variation of Citric Acid, Tartrate Acid and Sodium Bicarbonate. 1stMuhammadiyah International Conference on Health and Pharmaceutical Development. 2018; 54-60.
         8. .Subhashis Debnath, C. Navya Yadav, N. Nowjiya, M. Prabhavathi, A. SaiKumar, P. Sai.Krishna, M. Niranjan Babu. A Review on Natural Binders used in Pharmacy.Asian Journal of Pharmaceutical Research (AJPRes.). 2019; 9(1): 55-60.
         9. .U.D. Chavan. Mucilage from Okra (Abelmoschus esculentus) Cortex - Extraction andCultivation Evaluation. Article in Journal of Food Science and Technology –Mysore. 2003.
         10. Tavakoli N1, GhassemiDehkordi N1, Teimouri R1, Hamishehkar. Characterization and evaluation of okra gum as a tablet binder. Jundishapur Journal of Natural Pharmaceutical Products.2008; 3(1): 33-38.
         11. Kunal Pala, b.Synthesis, characterization of Okra mucilage as a potential new age therapeutic intervention MOL2NET. International Conference Series onMultidisciplinary Sciences. 2020; 6(1): 2624-5078.
         12. Ameena K, Dilip C, Saraswathi R, Krishnan PN, Sankar C, Simi SP. Isolation of the mucilage’s from Hibiscus rosasinensislinn. and Okra (Abelmoschus esculentus linn.) and studies of the binding effects of the mucilage’s.Asian Pacific Journal of Tropical Medicine. 2010; 1:529-543.
         13. . Nargis Sultana Chowdhury, Sifat Jamaly, Farhana Farjana, Nadira Begum, Elina AkherZenat.Review on Ethnomedicinal, Pharmacological, phytochemical and pharmaceutical profile of lady’s finger (Abelmoschus esculents) Plant. Pharmacology & Pharmacy. 2019; 10: 94-108.
         14. Bhatia Meenakshi and SangwaiyaPrerna. Synthesis, Optimisation and Evaluation of Okra Mucilage as Mucoadhesive Polymer. Scholars Research Library. 2016; 8(11): 159-163.
         15. Nitin  Sharma1,  Giriraj  T  Kulkarni  and  Anjana  Sharma. Development    ofAbelmoschus    esculentus    (Okra)- Based Mucoadhesive Gel for Nasal Delivery Rizatriptan Benzoate. Tropical Journal of Pharmaceutical Research. 2013; 12(2): 149-153.
         16. Shayeri Chatterjee, Rana Mazumdar. Novel approach of extraction and characterization of okra gum as a binder for tablet formulation. Asian journal of pharmaceutical and clinical research.2019; 12(1): 189-192.
         17. Habtamu FekaduGemede, Negussie Ratta, Gulelat Desse Haki, AshagrieWoldegiorgis4 and Fekadu Beyene. Nutritional Quality and Health Benefits of Okra (Abelmoschus esculentus): A Review. Journal of Food Processing & Technology. 2015; 6(6): 1-6.
         18. Soma Das1, Dr. Gouranga Nandi2, Prof. (Dr.) L. K. Ghosh. Okra and its various applications in Drug Delivery, Food Technology, Health Care and Pharmacological Aspects -A Review. Journal of pharmaceutical sciences and research. 2019; 11(6): 2139-2147.
         19. Made DwiWidyantari, Luh Putu Wrasiati and I. NengahKencana Putra. Characteristics of Effervescent Granules Extract of Kenikir (Cosmos caudatusKunth) Leaf with Various Acid Compositions as Alternative Functional Beverage Product. International Journal of Current Microbiology and Applied Sciences. 2021; 10(8): 1-8.
         20. Indian Pharmacopoeia. 2018; 2: 1274-1276, 1642, 1706-1707.
         21. Indian Pharmacopoeia. 2018; 3: 3312-3313, 3207, 3157-3158.
         22. Vijayalaxmi Kamaraddi, Sharath Kumar M., Chaitra Nayaka M. K., Kulpat iHipparagi and Sarojini J. Standardization of Banana flour and Banana powder to ensure economic and nutritional security. International conference on food technology.2010; 2: 30-31.