FORMULATION, DEVELOPMENT, AND EVALUATION OF IMMEDIATE-RELEASE CAFFEINE ANHYDROUS CAPSULES (100 MG)

The aim of this study is to formulate, develop, and evaluate immediate-release capsules containing 100 mg of Caffeine Anhydrous. Three different formulations (F1, F2, F3) were developed using the wet granulation technique. These formulations were developed to compare the influence of different diluent-based excipient matrices (specifically Mannitol, Lactose Monohydrate, and Dicalcium Phosphate) on drug release profiles. Pre-filling evaluations of the prepared granules of all batches showed excellent micromeritic flow properties, with Carr's index ranging from 5.71% to 9.72% and angle of repose between 21.94° and 22.44°. The prepared granules were filled into size-0 hard gelatin capsules. All formulations successfully passed the acceptable limits for weight variation, locking length, and content uniformity. In-vitro disintegration times were also rapid, occurring within 2 to 6 minutes. In-vitro dissolution studies were conducted in a pH 1.2 buffer as the dissolution medium. Formulation F1 (Mannitol-based) exhibited the most rapid and complete drug release compared to F2 and F3. Microbial content testing confirmed that F1 is microbiologically safe. Therefore, the wet granulation method successfully produced immediate-release caffeine capsules.

• Tiwari S, Batra N. Oral Drug Delivery System: A Review. American Journal of Life Science Research 2014; 2(1): 27-35.
• Aliyu RS, Lawal AM, Chasta P, Sharma GK. Capsules: Types, manufacturing, formulation, quality control test and, packaging and storage-A comprehensive review. World Journal of Pharmaceutical and Life Sciences, 2020; 6(8):       93-104.
• Kavya SU, Annapoorna T, Shifa SU, Prashant HK, Ahmmod R, Alom M. A comprehensive review on the formulation, manufacturing and evaluation of pharmaceutical capsules. World Journal of Pharmaceutical Research, 2026; 15(13): 316-335.
• Patil YG, Badgujar AN, Chavan SU, Pinjari KB, Pardeshi MS. Exploring the evaluation of capsule dosage forms: A comprehensive review. International Journal of Pharmaceutical Research and Development, 2025; 7(1): 89-99.
• Rodak K, Kokot I, Kratz EM. Caffeine as a Factor Influencing the Functioning of the Human Body—Friend or Foe? Nutrients, 2021; 13: 3088. https://doi.org/10.3390/nu13093088
• Nehlig A, Daval Jean-Luc, Debry G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Elsevier, 1992; 17(2): 139-170.
• Sharma V, Sharma A, Verma KK, Gaur PK, Kaushik R, Abdali B. A comprehensive review on pharmacological potentials of caffeine. Journal of Applied Pharmaceutical Sciences and Research, 2023; 6(3): 16-26.
• Reddy VS, Shiva S, Manikantan S, Ramakrishna S. Pharmacology of caffeine and its effects on the human body. European Journal of Medicinal Chemistry Reports, 2024; 10: 100138.
• Rao PSV, Nagaraju G, Sanjeev L, Sana MD, Shivani T, Sahithya V. Formulation and evaluation of immediate release tablets of bedaquiline. International Journal of Pharmaceutical Research and Applications, 2025; 10(3): 1526-1534.
• Wakchaure S, Kale S, Shelke S, Kanase S, Thombare S. A detailed review on the use of excipients in drug formulation. International Journal of Pharmaceutical Sciences, 2024; 2(7): 1919-1926.
• Das S, Dutta K, Goswami R, Bhattacharya J, Chakrabarty S. Pharmaceutical excipients and their elaborative approach. International Journal of Pharmaceutical Sciences and Research, 2025; 16(12): 3200-3221. 
• Alam K, Shareef H, Bushra R. Formulation development and evaluation of caffeine tablets (200 mg) by direct compression. International Journal of Drug Development and Research, 2013; 5(3):            371-376.
• Palma ASA, Sverrisdottir GL, Guobjargardottir PO, Axelsdottir S. Formulation development for first-order release caffeine tablets. [B.Sc. Thesis]. Faculty of Pharmaceutical Sciences, School of Health Sciences, University of Iceland; June 2022.
• Hjaltason, Ulfarsson MG, Bondarow U. Development of caffeine tablets exhibiting similar dissolution profile to reference tablets. [B.Sc. Thesis]. Faculty of Pharmaceutical Sciences, School of Health Sciences, University of Iceland; June 2023.
• Al-Ragawi AAMM. Pharmaceutical excipients: their roles, impact on stability and bioavailability, and mechanisms of interaction. ResearchGate 2025. Available from: https://www.researchgate.net/publication/395459045
• Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Vol 1. Ghaziabad: The Indian Pharmacopoeia Commission, 2007.
• United States Pharmacopeial Convention. The United States Pharmacopeia 25 and The National Formulary 20. Asian ed. Rockville, MD: United States Pharmacopeial Convention, Inc., 2002.
• Sinko PJ, editor. Martin's Physical Pharmacy and Pharmaceutical Sciences. Lippincott Williams & Wilkins, 6th Edition, 2011.
• Khar RK, Vyas SP, Ahmad FJ, Jain GK, editors. Lachman/Lieberman's The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors Pvt. Ltd, 4th Edition, 2016.
• Abbasiliasi S, Shun T J, Ibrahim T A T, Ismail N, Ariff A B, Mokhtar N K, Mustafa S. Use of sodium alginate in the preparation of gelatin-based hard capsule shells and their evaluation in vitro. RSC Advances, 2019; 9: 16147–16157.  DOI:10.1039/c9ra01791g