Optimizing Oral Contraceptives: Role of Immediate Release Formulations in Reproductive Health
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Zenodo
2025
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| author | Shivshankar Nagrik*1, Ashwini Verulkar2, Aishwarya Ade2, Rutuja Gaikwad2, Mayuri Shelke2, Khushbu Akturkar2, Snehal Dethe2, Sakshi Tupe2, Prachi Jumale2, Mohini Kale2, Janhavi Gadhe2, Kalyani Deshpande3, Vaishnavi Sarode4, Vaishnavi Puri5, Monika Girhe6, Nikhil Wagh6, Pallavi Mangulkar7 |
| author_facet | Shivshankar Nagrik*1, Ashwini Verulkar2, Aishwarya Ade2, Rutuja Gaikwad2, Mayuri Shelke2, Khushbu Akturkar2, Snehal Dethe2, Sakshi Tupe2, Prachi Jumale2, Mohini Kale2, Janhavi Gadhe2, Kalyani Deshpande3, Vaishnavi Sarode4, Vaishnavi Puri5, Monika Girhe6, Nikhil Wagh6, Pallavi Mangulkar7 |
| contents | <p><span>Oral contraceptive drugs are a cornerstone of reproductive healthcare, offering reliable and reversible birth control through hormonal modulation. This comprehensive review delves into the design and development of immediate release (IR) dosage forms for oral contraceptives, focusing on their pharmacological, formulation, and regulatory perspectives. IR tablets, commonly used in both progestin-only pills (POPs) and combined oral contraceptives (COCs), are engineered to ensure rapid disintegration and absorption of active pharmaceutical ingredients, such as ethinylestradiol and levonorgestrel. The review elaborates on key formulation strategies, including the selection of superdisintegrants, solubility and permeability enhancement techniques, and modern excipient technologies that support bioavailability and patient compliance. It discusses the challenges associated with IR formulations, such as strict adherence requirements, fluctuations in plasma hormone levels, and susceptibility to first-pass metabolism. Further emphasis is placed on the impact of manufacturing techniques like direct compression and granulation on dosage performance and quality control. Regulatory frameworks provided by the USFDA, EMA, and CDSCO are explored, with attention to bioequivalence, dissolution testing, and pharmacovigilance. The role of in vitro-in vivo correlation (IVIVC) is also addressed, highlighting its relevance in bridging laboratory findings with clinical efficacy. The review concludes by identifying opportunities for innovation in formulation science to enhance the safety, effectiveness, and accessibility of IR oral contraceptives, ultimately supporting better reproductive health outcomes globally</span><span>.</span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_15818035 |
| institution | Zenodo |
| language | |
| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Optimizing Oral Contraceptives: Role of Immediate Release Formulations in Reproductive Health Shivshankar Nagrik*1, Ashwini Verulkar2, Aishwarya Ade2, Rutuja Gaikwad2, Mayuri Shelke2, Khushbu Akturkar2, Snehal Dethe2, Sakshi Tupe2, Prachi Jumale2, Mohini Kale2, Janhavi Gadhe2, Kalyani Deshpande3, Vaishnavi Sarode4, Vaishnavi Puri5, Monika Girhe6, Nikhil Wagh6, Pallavi Mangulkar7 Oral contraceptives, Progestin-only pills, Combined oral contraceptives, bioavailability, Superdisintegrants, Regulatory guidelines <p><span>Oral contraceptive drugs are a cornerstone of reproductive healthcare, offering reliable and reversible birth control through hormonal modulation. This comprehensive review delves into the design and development of immediate release (IR) dosage forms for oral contraceptives, focusing on their pharmacological, formulation, and regulatory perspectives. IR tablets, commonly used in both progestin-only pills (POPs) and combined oral contraceptives (COCs), are engineered to ensure rapid disintegration and absorption of active pharmaceutical ingredients, such as ethinylestradiol and levonorgestrel. The review elaborates on key formulation strategies, including the selection of superdisintegrants, solubility and permeability enhancement techniques, and modern excipient technologies that support bioavailability and patient compliance. It discusses the challenges associated with IR formulations, such as strict adherence requirements, fluctuations in plasma hormone levels, and susceptibility to first-pass metabolism. Further emphasis is placed on the impact of manufacturing techniques like direct compression and granulation on dosage performance and quality control. Regulatory frameworks provided by the USFDA, EMA, and CDSCO are explored, with attention to bioequivalence, dissolution testing, and pharmacovigilance. The role of in vitro-in vivo correlation (IVIVC) is also addressed, highlighting its relevance in bridging laboratory findings with clinical efficacy. The review concludes by identifying opportunities for innovation in formulation science to enhance the safety, effectiveness, and accessibility of IR oral contraceptives, ultimately supporting better reproductive health outcomes globally</span><span>.</span></p> |
| title | Optimizing Oral Contraceptives: Role of Immediate Release Formulations in Reproductive Health |
| topic | Oral contraceptives, Progestin-only pills, Combined oral contraceptives, bioavailability, Superdisintegrants, Regulatory guidelines |
| url | https://doi.org/10.5281/zenodo.15818035 |