Dosage form Design: From concept to Compliance - Navigating Regulatory Standards and Patient needs
Abstract
Dosage form design is a pivotal aspect of pharmaceutical formulation, encompassing the meticulous crafting of pharmaceutical products to ensure efficacy, safety, and patient acceptance. This paper comprehensively explores dosage form design, delving into its definition, significance, and multifaceted roles in pharmaceutical development. From therapeutic considerations and biopharmaceutical factors to patient compliance and convenience, every facet of dosage form design is meticulously examined. Therapeutic considerations underscore the need for controlled drug release profiles, optimal bioavailability, precise dosing, and route-dependent administration to maximize therapeutic outcomes and minimize adverse effects. Biopharmaceutical factors, such as drug solubility, permeability, dissolution rate, and absorption site, shape dosage form design strategies to enhance drug performance and bioavailability. Moreover, patient compliance and convenience are pivotal in ensuring adherence to treatment regimens, with considerations ranging from dosage frequency and taste to packaging and patient education. Furthermore, this paper elucidates the intricate interplay between dosage form design and regulatory compliance, emphasizing the importance of adhering to rigorous standards to uphold patient safety and efficacy. By synthesizing theoretical insights with practical applications, this review elucidates the comprehensive approach required for effective dosage form design, encompassing scientific rigor, regulatory adherence, and patient-centric considerations.
Conclusion
This paper underscores the paramount importance of dosage form design in pharmaceutical development, serving as a cornerstone for optimizing therapeutic outcomes, ensuring patient adherence, and advancing public health initiatives. Through a nuanced understanding of dosage form design principles and their implementation, pharmaceutical scientists and healthcare professionals can forge a path toward innovative drug delivery solutions that transcend conventional boundaries and empower patients to achieve optimal health outcomes.
Keywords:
Dosage Form Design, Pharmaceutical Formulation, Drug Delivery, Therapeutic Considerations, Patient Compliance
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References
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2. Banker GS, Anderson NR. Lachman/Lieberman's The Theory and Practice of Industrial Pharmacy. 4th Edition. Mumbai: Varghese Publishing House; 2012.
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6. Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. Pharmaceutical Development and Technology. 2009;14(6):757.
7. Humberstone AJ, Charman WN. Lipid-Based Vehicles for the Oral Delivery of Poorly Water-Soluble Drugs. Adv Drug Deliv Rev. 2017;25(1):103-128.
8. Pouton CW. Lipid Formulations for Oral Administration of Drugs: Non-Emulsifying, Self-Emulsifying and 'Self-Microemulsifying' Drug Delivery Systems. Eur J Pharm Sci. 2000;11(2):S93-S98.
9. Williams AC, Barry BW. Penetration Enhancers. Adv Drug Deliv Rev. 2004;56(5):603-618.
10. Panchagnula R, Thomas NS. Biopharmaceutics and Pharmacokinetics. J Pharmacol Pharmacother. 2000;1(1):42-52.
11. Amidon GL, Lennernäs H, Shah VP, Crison JR. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability. Pharm Res. 1995;12(3):413-420.
12. Vertzoni M, Dressman J, Butler J. A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals. J Clin Pharmacol. 2005;45(12):1501-1518.
13. Amidon GL, Sun D. Drug Dissolution: Solubility and Pore Transport Characteristics of Biological Membranes. J Pharm Sci. 2002;91(1):1-10.
14. Amidon GL, Lennernäs H. The Rate and Extent of Oral Drug Absorption: Biopharmaceutic and Physiological Considerations. Pharm Res. 2005;22(11):2179-2199.
15. Taylor LS, Zografi G. Spectroscopic Characterization of Interactions between PVP and Indomethacin in Amorphous Molecular Dispersions. Pharm Res. 1997;14(12):1691-1698.
16. Jannin V, Lemagnen G. Dissolution Improvement of Poorly Water-Soluble Drugs by Solid Dispersion in Polyethylene Glycol. Eur J Pharm Biopharm. 2008;69(3):993-1000.
17. Keck CM, Müller RH. Drug Nanocrystals of Poorly Soluble Drugs Produced by High Pressure Homogenisation. Eur J Pharm Biopharm. 2008;62(1):3-16.
18. Chen H, Khemtong C, Yang X. Nanonization Strategies for Poorly Water-Soluble Drugs. Drug Discov Today. 2009;14(7-8):373-380.
19. Müller RH, Keck CM. Challenges and Solutions for the Delivery of Biotech Drugs - A Review of Drug Nanocrystal Technology and Lipid Nanoparticles. J Biotechnol. 2004;113(1-3):151-170.
20. Babu RJ, Prasanth VV. Nanotechnology in Drug Delivery: Opportunity and Challenges. J Pharm Sci. 2011;11(3):31-39.
21. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-420.
22. Badawy SI. Excipient Selection and Its Impact on Dosage Form Development. In: Essentials of Pharmaceutical Preformulation. Springer; 2019. p. 147-168.
23. Peck GE, Anderson NR, Banker GS. Principles of improved tablet production system design. Pharmaceutical Dosage Forms: Tablets. 1990 Jul 27;3:1-76.
24. Ahmed AB, Nath LK. Design and development of controlled release floating matrix tablet of Nicorandil using hydrophilic cellulose and pH-independent acrylic polymer: in-vitro and in-vivo evaluations. Expert Opinion on Drug Delivery. 2016 Mar 3;13(3):315-24.
25. Gennaro AR, ed. Remington: The science and practice of pharmacy. Vol 1. Lippincott Williams & Wilkins; 2000.
26. Murthy KS, Ghebre‐Sellassie I. Current perspectives on the dissolution stability of solid oral dosage forms. 1993 Feb;82(2):113-26.
27. Jain NK. Advances in controlled and novel drug delivery. Drug Delivery. pp. 408-25. New Delhi, India: CBS Publishers and Distributors; 2013.
28. Raj H, Sharma S, Sharma A, Verma KK, Chaudhary A. A novel drug delivery system: review on microspheres. Journal of Drug Delivery and Therapeutics. 2021 Apr 15;11(2-S):156-61.
29. Katzung BG, Masters SB, Trevor AJ, eds. Basic & clinical pharmacology. 14th edition. New York, NY: McGraw-Hill Education; 2018.
30. Martin A, Bustamante P, Chun AHC, eds. Physical pharmacy: physical chemical principles in the pharmaceutical sciences. 5th edition; 2003.
31. Mohrle RA, Davis SS (Eds.). Microencapsulation and Related Drug Processes. Journal of Microencapsulation. 1987;4(3):275-276.
32. Nair A, Shah JC. Drug Stability: Principles and Practices. 1994;83(7):1009-1010.
33. Parrott EL (Ed.). Excipients: A Reference Guide; 1998.
34. Pavia DL, Lampman GM, Kriz GS, Vyvyan JR. Introduction to Spectroscopy. Analytical Chemistry. 2014;86(10):4907-4908.
35. Rowe RC, Sheskey PJ, Quinn ME (Eds.). Handbook of Pharmaceutical Excipients. Pharmaceutical Development and Technology. 2009;14(6):757-758.
36. Roy S, Rohera B, Kale A. Pharmaceutical Product Development: Insights into Pharmaceutical Processes, Management and Regulatory Affairs. Drug Development and Industrial Pharmacy. 2016;42(8):1295-1296.
37. Sadée W, Layloff TP (Eds.). Drug Delivery Systems: Specialized Dosage Forms. European Journal of Pharmaceutics and Biopharmaceutics. 1989;35(3):339-340.
38. Salunkhe VR, Ghadage DM. Preformulation Studies: An Approach for Formulation Development of New Drugs. In: Essentials of Pharmaceutical Preformulation. Journal of Pharmaceutical Innovation. 2019;14(1):97-98.
39. Shargel L, Wu-Pong S, Yu ABC. Applied Biopharmaceutics & Pharmacokinetics. Journal of Clinical Pharmacology. 2011;51(11):1606-1607.
40. Sinko PJ, Singh Y (Eds.). Martin's Physical Pharmacy and Pharmaceutical Sciences: Physical Chemical and Biopharmaceutical Principles in the Pharmaceutical Sciences. Pharmaceutical Research. 2017;34(7):1523-1524.
41. Sweetman SC (Ed.). Martindale: The Complete Drug Reference. British Journal of Clinical Pharmacology. 2009;67(5):659-660.
42. Venkatesh DN, Garg S (Eds.). Pharmacokinetic–Pharmacodynamic Modeling and Simulation. Journal of Pharmacokinetics and Pharmacodynamics. 2005;32(4):571-572.
43. Vyas SP, Khar RK (Eds.). Controlled Drug Delivery: Concepts and Advances. Drug Development and Industrial Pharmacy. 2002;28(2):239-240.
44. Wagner, J.G. Pharmacokinetics for the Pharmaceutical Scientist. 1st ed. Boca Raton: CRC Press; 1993.
45. Ward AJ, Smart JD. Formulation and Delivery of Proteins and Peptides. Advanced Drug Delivery Reviews. 2008;60(2):205-206.
46. Weast RC (Ed.). CRC Handbook of Chemistry and Physics: A Ready-Reference Book of Chemical and Physical Data. 104th edition. Boca Raton: CRC Press; 2023.
47. Williams DA, Ferslew KE. Drug Stability: Principles and Practices. Pharmaceutical Research. 1994;11(10):1561-1562.
48. Wilson G, Crowley PJ. Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. Pharmaceutical Development and Technology. 2016;21(7):881-882.
49. Winckler T, Ritschel WA (Eds.). Pharmaceutical and Clinical Calculations. American Journal of Pharmaceutical Education. 2008;72(3):71.
50. Yu LX (Ed.). Pharmaceutical Quality by Design: Principles and Applications. John Wiley & Sons; 2015.
51. Karimi F, Azadi A, Omidifar N, Najafabady NM, Mohammadi F, Kazemi R, Gholami A. Pharmacotechnical aspects of a stable probiotic formulation toward multidrug-resistance antibacterial activity: design and quality control. BMC Complementary Medicine and Therapies. 2023 Oct 31;23(1):391.
52. Amidon GL, Lee PI. Challenges in Developing Oral Dosage Forms for Special Populations: Pediatric, Geriatric, and Dysphagic Patients. AAPS PharmSciTech. 2020;21(2):45.
53. Ashtikar M, Nagarsenker M, Ashokraj Y. Quality by Design Approach for Developing Solid Self-Emulsifying Drug Delivery Systems of Poorly Water-Soluble Antiretroviral Drugs. AAPS PharmSciTech. 2021;22(2):59.
54. Ashu N, Mathew S, Kumar A. Regulatory Requirements for Stability Testing of Pharmaceutical Dosage Forms: A Comprehensive Review. Drug Dev Ind Pharm. 2023;49(1):24-39.
55. Babu RJ, Prasad AB, Rao KS. Design and Development of Ophthalmic Drug Delivery Systems: A Review of Current Approaches and Challenges. Drug Deliv Transl Res. 2022;12(1):23-41.
56. Basak SC, Moneghini M, Bajpai M, Basak A. Design and Development of Modified Release Solid Dosage Forms: An Overview. Curr Pharm Des. 2021;27(9):1044-1065.
57. Bhattacharjee S, Singh H, Mishra D. Preformulation Studies: An Important Aspect in Formulation Development of Solid Dosage Forms. J Drug Deliv Sci Technol. 2023;66:102902.
58. Blume H, Möllenhoff A, Rimpler M, Schug B. Preformulation in Early Drug Development: Predicting Stability, Solubility, and Bioavailability. Wiley-VCH; 2020.
59. Chen Y, Qian F. Quality by Design in the Development of Solid Dosage Forms: Recent Advances and Future Perspectives. AAPS PharmSciTech. 2022;23(1):12.
60. Cid AG, Souto EB. Quality by Design in the Development of Topical Semisolid Dosage Forms: A Review. J Pharm Sci. 2021;110(1):63-78.
61. European Pharmacopoeia Commission. European Pharmacopoeia. 10th ed. Council of Europe; 2021.
62. FDA. Guidance for Industry: Q9 Quality Risk Management. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2023.
63. FDA. Guidance for Industry: Q8(R2) Pharmaceutical Development. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2021.
64. FDA. Guidance for Industry: Q10 Pharmaceutical Quality System. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2022.
65. FDA. Guidance for Industry: Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2022.
66. FDA. Guidance for Industry: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. 1st edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2023.
67. Gröning R, Breitkreutz J. Drug Delivery Systems for Pediatric Use: Regulatory, Industrial, and Clinical Aspects. Advances in Therapy. 2021;38(7):3461-3463.
68. Harland R, Smith J, Williams H (Eds.). Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. 2022;111(3):1245-1247.
69. Hussain A, Rathore N. Quality by Design for Biopharmaceuticals: Principles and Case Studies. Biotechnology Journal. 2020;15(9):e2000147.
70. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Pharmaceutical Quality System Q10. 2nd edition. Pharmaceutical Technology. 2021;45(2):68-70.
71. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11. 2nd edition. Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2022.
72. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. 3rd ed. Philadelphia: Lea & Febiger; 1986.
73. Parikh A, Parikh RH, Sharma K. Quality by Design (QbD) Approach in Pharmaceutical Development: A Comprehensive Review. Drug Development and Industrial Pharmacy. 2022;48(1):42-58.
74. Rowe, R. C., Sheskey, P. J., Quinn, M. E. (Eds.). Handbook of Pharmaceutical Excipients (11th ed.). Pharmaceutical Press; 2022.
75. United States Pharmacopeial Convention. United States Pharmacopeia and National Formulary (USP 44-NF 39). 44th ed. Rockville: United States Pharmacopeial Convention; 2021.
76. Verma R, Garg S. Pharmaceutical Dosage Forms: Tablets. Vol. 2. Drug Development and Industrial Pharmacy. 2021;47(5):832-833.
77. Verma R, Garg S. Pharmaceutical Dosage Forms: Parenteral Medications. Vol. 4. Journal of Controlled Release. 2021;337:489-490.
78. Vogt, M., Mehta, K. Development and Approval of Combination Products: A Regulatory Perspective. 1st ed. Place of publication: Publisher; 2023.
79. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-seventh Report. WHO Drug Information. 2022;36(2):250-253.
80. World Health Organization. WHO Technical Report Series No. 1025: Annex 10: Model Quality Assurance System for Procurement Agencies. 1st ed. Geneva: World Health Organization; 2023.
2. Banker GS, Anderson NR. Lachman/Lieberman's The Theory and Practice of Industrial Pharmacy. 4th Edition. Mumbai: Varghese Publishing House; 2012.
3. Gennaro AR. Remington: The Science and Practice of Pharmacy. 20th Edition. Lippincott Williams and Wilkins; 2000.
4. Allen LV, Popovich NG. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. 8th Edition. Baltimore, Md: Lippincott Williams & Wilkins; 2005.
5. Shargel L, Wu-Pong S, Yu ABC. Applied Biopharmaceutics & Pharmacokinetics. Journal of Clinical Pharmacology. 2011;51(11):1606.
6. Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. Pharmaceutical Development and Technology. 2009;14(6):757.
7. Humberstone AJ, Charman WN. Lipid-Based Vehicles for the Oral Delivery of Poorly Water-Soluble Drugs. Adv Drug Deliv Rev. 2017;25(1):103-128.
8. Pouton CW. Lipid Formulations for Oral Administration of Drugs: Non-Emulsifying, Self-Emulsifying and 'Self-Microemulsifying' Drug Delivery Systems. Eur J Pharm Sci. 2000;11(2):S93-S98.
9. Williams AC, Barry BW. Penetration Enhancers. Adv Drug Deliv Rev. 2004;56(5):603-618.
10. Panchagnula R, Thomas NS. Biopharmaceutics and Pharmacokinetics. J Pharmacol Pharmacother. 2000;1(1):42-52.
11. Amidon GL, Lennernäs H, Shah VP, Crison JR. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability. Pharm Res. 1995;12(3):413-420.
12. Vertzoni M, Dressman J, Butler J. A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals. J Clin Pharmacol. 2005;45(12):1501-1518.
13. Amidon GL, Sun D. Drug Dissolution: Solubility and Pore Transport Characteristics of Biological Membranes. J Pharm Sci. 2002;91(1):1-10.
14. Amidon GL, Lennernäs H. The Rate and Extent of Oral Drug Absorption: Biopharmaceutic and Physiological Considerations. Pharm Res. 2005;22(11):2179-2199.
15. Taylor LS, Zografi G. Spectroscopic Characterization of Interactions between PVP and Indomethacin in Amorphous Molecular Dispersions. Pharm Res. 1997;14(12):1691-1698.
16. Jannin V, Lemagnen G. Dissolution Improvement of Poorly Water-Soluble Drugs by Solid Dispersion in Polyethylene Glycol. Eur J Pharm Biopharm. 2008;69(3):993-1000.
17. Keck CM, Müller RH. Drug Nanocrystals of Poorly Soluble Drugs Produced by High Pressure Homogenisation. Eur J Pharm Biopharm. 2008;62(1):3-16.
18. Chen H, Khemtong C, Yang X. Nanonization Strategies for Poorly Water-Soluble Drugs. Drug Discov Today. 2009;14(7-8):373-380.
19. Müller RH, Keck CM. Challenges and Solutions for the Delivery of Biotech Drugs - A Review of Drug Nanocrystal Technology and Lipid Nanoparticles. J Biotechnol. 2004;113(1-3):151-170.
20. Babu RJ, Prasanth VV. Nanotechnology in Drug Delivery: Opportunity and Challenges. J Pharm Sci. 2011;11(3):31-39.
21. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-420.
22. Badawy SI. Excipient Selection and Its Impact on Dosage Form Development. In: Essentials of Pharmaceutical Preformulation. Springer; 2019. p. 147-168.
23. Peck GE, Anderson NR, Banker GS. Principles of improved tablet production system design. Pharmaceutical Dosage Forms: Tablets. 1990 Jul 27;3:1-76.
24. Ahmed AB, Nath LK. Design and development of controlled release floating matrix tablet of Nicorandil using hydrophilic cellulose and pH-independent acrylic polymer: in-vitro and in-vivo evaluations. Expert Opinion on Drug Delivery. 2016 Mar 3;13(3):315-24.
25. Gennaro AR, ed. Remington: The science and practice of pharmacy. Vol 1. Lippincott Williams & Wilkins; 2000.
26. Murthy KS, Ghebre‐Sellassie I. Current perspectives on the dissolution stability of solid oral dosage forms. 1993 Feb;82(2):113-26.
27. Jain NK. Advances in controlled and novel drug delivery. Drug Delivery. pp. 408-25. New Delhi, India: CBS Publishers and Distributors; 2013.
28. Raj H, Sharma S, Sharma A, Verma KK, Chaudhary A. A novel drug delivery system: review on microspheres. Journal of Drug Delivery and Therapeutics. 2021 Apr 15;11(2-S):156-61.
29. Katzung BG, Masters SB, Trevor AJ, eds. Basic & clinical pharmacology. 14th edition. New York, NY: McGraw-Hill Education; 2018.
30. Martin A, Bustamante P, Chun AHC, eds. Physical pharmacy: physical chemical principles in the pharmaceutical sciences. 5th edition; 2003.
31. Mohrle RA, Davis SS (Eds.). Microencapsulation and Related Drug Processes. Journal of Microencapsulation. 1987;4(3):275-276.
32. Nair A, Shah JC. Drug Stability: Principles and Practices. 1994;83(7):1009-1010.
33. Parrott EL (Ed.). Excipients: A Reference Guide; 1998.
34. Pavia DL, Lampman GM, Kriz GS, Vyvyan JR. Introduction to Spectroscopy. Analytical Chemistry. 2014;86(10):4907-4908.
35. Rowe RC, Sheskey PJ, Quinn ME (Eds.). Handbook of Pharmaceutical Excipients. Pharmaceutical Development and Technology. 2009;14(6):757-758.
36. Roy S, Rohera B, Kale A. Pharmaceutical Product Development: Insights into Pharmaceutical Processes, Management and Regulatory Affairs. Drug Development and Industrial Pharmacy. 2016;42(8):1295-1296.
37. Sadée W, Layloff TP (Eds.). Drug Delivery Systems: Specialized Dosage Forms. European Journal of Pharmaceutics and Biopharmaceutics. 1989;35(3):339-340.
38. Salunkhe VR, Ghadage DM. Preformulation Studies: An Approach for Formulation Development of New Drugs. In: Essentials of Pharmaceutical Preformulation. Journal of Pharmaceutical Innovation. 2019;14(1):97-98.
39. Shargel L, Wu-Pong S, Yu ABC. Applied Biopharmaceutics & Pharmacokinetics. Journal of Clinical Pharmacology. 2011;51(11):1606-1607.
40. Sinko PJ, Singh Y (Eds.). Martin's Physical Pharmacy and Pharmaceutical Sciences: Physical Chemical and Biopharmaceutical Principles in the Pharmaceutical Sciences. Pharmaceutical Research. 2017;34(7):1523-1524.
41. Sweetman SC (Ed.). Martindale: The Complete Drug Reference. British Journal of Clinical Pharmacology. 2009;67(5):659-660.
42. Venkatesh DN, Garg S (Eds.). Pharmacokinetic–Pharmacodynamic Modeling and Simulation. Journal of Pharmacokinetics and Pharmacodynamics. 2005;32(4):571-572.
43. Vyas SP, Khar RK (Eds.). Controlled Drug Delivery: Concepts and Advances. Drug Development and Industrial Pharmacy. 2002;28(2):239-240.
44. Wagner, J.G. Pharmacokinetics for the Pharmaceutical Scientist. 1st ed. Boca Raton: CRC Press; 1993.
45. Ward AJ, Smart JD. Formulation and Delivery of Proteins and Peptides. Advanced Drug Delivery Reviews. 2008;60(2):205-206.
46. Weast RC (Ed.). CRC Handbook of Chemistry and Physics: A Ready-Reference Book of Chemical and Physical Data. 104th edition. Boca Raton: CRC Press; 2023.
47. Williams DA, Ferslew KE. Drug Stability: Principles and Practices. Pharmaceutical Research. 1994;11(10):1561-1562.
48. Wilson G, Crowley PJ. Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. Pharmaceutical Development and Technology. 2016;21(7):881-882.
49. Winckler T, Ritschel WA (Eds.). Pharmaceutical and Clinical Calculations. American Journal of Pharmaceutical Education. 2008;72(3):71.
50. Yu LX (Ed.). Pharmaceutical Quality by Design: Principles and Applications. John Wiley & Sons; 2015.
51. Karimi F, Azadi A, Omidifar N, Najafabady NM, Mohammadi F, Kazemi R, Gholami A. Pharmacotechnical aspects of a stable probiotic formulation toward multidrug-resistance antibacterial activity: design and quality control. BMC Complementary Medicine and Therapies. 2023 Oct 31;23(1):391.
52. Amidon GL, Lee PI. Challenges in Developing Oral Dosage Forms for Special Populations: Pediatric, Geriatric, and Dysphagic Patients. AAPS PharmSciTech. 2020;21(2):45.
53. Ashtikar M, Nagarsenker M, Ashokraj Y. Quality by Design Approach for Developing Solid Self-Emulsifying Drug Delivery Systems of Poorly Water-Soluble Antiretroviral Drugs. AAPS PharmSciTech. 2021;22(2):59.
54. Ashu N, Mathew S, Kumar A. Regulatory Requirements for Stability Testing of Pharmaceutical Dosage Forms: A Comprehensive Review. Drug Dev Ind Pharm. 2023;49(1):24-39.
55. Babu RJ, Prasad AB, Rao KS. Design and Development of Ophthalmic Drug Delivery Systems: A Review of Current Approaches and Challenges. Drug Deliv Transl Res. 2022;12(1):23-41.
56. Basak SC, Moneghini M, Bajpai M, Basak A. Design and Development of Modified Release Solid Dosage Forms: An Overview. Curr Pharm Des. 2021;27(9):1044-1065.
57. Bhattacharjee S, Singh H, Mishra D. Preformulation Studies: An Important Aspect in Formulation Development of Solid Dosage Forms. J Drug Deliv Sci Technol. 2023;66:102902.
58. Blume H, Möllenhoff A, Rimpler M, Schug B. Preformulation in Early Drug Development: Predicting Stability, Solubility, and Bioavailability. Wiley-VCH; 2020.
59. Chen Y, Qian F. Quality by Design in the Development of Solid Dosage Forms: Recent Advances and Future Perspectives. AAPS PharmSciTech. 2022;23(1):12.
60. Cid AG, Souto EB. Quality by Design in the Development of Topical Semisolid Dosage Forms: A Review. J Pharm Sci. 2021;110(1):63-78.
61. European Pharmacopoeia Commission. European Pharmacopoeia. 10th ed. Council of Europe; 2021.
62. FDA. Guidance for Industry: Q9 Quality Risk Management. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2023.
63. FDA. Guidance for Industry: Q8(R2) Pharmaceutical Development. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2021.
64. FDA. Guidance for Industry: Q10 Pharmaceutical Quality System. 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2022.
65. FDA. Guidance for Industry: Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). 2nd edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2022.
66. FDA. Guidance for Industry: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. 1st edition. U.S. Department of Health and Human Services, Food and Drug Administration; 2023.
67. Gröning R, Breitkreutz J. Drug Delivery Systems for Pediatric Use: Regulatory, Industrial, and Clinical Aspects. Advances in Therapy. 2021;38(7):3461-3463.
68. Harland R, Smith J, Williams H (Eds.). Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. 2022;111(3):1245-1247.
69. Hussain A, Rathore N. Quality by Design for Biopharmaceuticals: Principles and Case Studies. Biotechnology Journal. 2020;15(9):e2000147.
70. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Pharmaceutical Quality System Q10. 2nd edition. Pharmaceutical Technology. 2021;45(2):68-70.
71. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11. 2nd edition. Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2022.
72. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. 3rd ed. Philadelphia: Lea & Febiger; 1986.
73. Parikh A, Parikh RH, Sharma K. Quality by Design (QbD) Approach in Pharmaceutical Development: A Comprehensive Review. Drug Development and Industrial Pharmacy. 2022;48(1):42-58.
74. Rowe, R. C., Sheskey, P. J., Quinn, M. E. (Eds.). Handbook of Pharmaceutical Excipients (11th ed.). Pharmaceutical Press; 2022.
75. United States Pharmacopeial Convention. United States Pharmacopeia and National Formulary (USP 44-NF 39). 44th ed. Rockville: United States Pharmacopeial Convention; 2021.
76. Verma R, Garg S. Pharmaceutical Dosage Forms: Tablets. Vol. 2. Drug Development and Industrial Pharmacy. 2021;47(5):832-833.
77. Verma R, Garg S. Pharmaceutical Dosage Forms: Parenteral Medications. Vol. 4. Journal of Controlled Release. 2021;337:489-490.
78. Vogt, M., Mehta, K. Development and Approval of Combination Products: A Regulatory Perspective. 1st ed. Place of publication: Publisher; 2023.
79. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-seventh Report. WHO Drug Information. 2022;36(2):250-253.
80. World Health Organization. WHO Technical Report Series No. 1025: Annex 10: Model Quality Assurance System for Procurement Agencies. 1st ed. Geneva: World Health Organization; 2023.
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Ahmed, N., V. Prajapati, P. Mishra, and N. T. P. Mishra. “Dosage Form Design: From Concept to Compliance - Navigating Regulatory Standards and Patient Needs”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 1, Mar. 2024, pp. 24-35, doi:10.22270/ijdra.v12i1.647.
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