Vaginal and Intrauterine Delivery Systems

Klein, Sandra; Tietz, Katharina

doi:10.1002/9781118675748.ch7

Cited by 3 publications

(3 citation statements)

References 60 publications

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“…Whereas drug release (dissolution) of water-soluble suppositories can be studied using the (mini) paddle or basket apparatus or the flow-through cell, as discussed earlier, drug release testing for lipophilic suppositories may need modification of the dissolution procedure to avoid analytical interference from the oil globules. As for lipophilic vaginal suppositories, a suitable method could be established based on EP chapter 2.9.42, Dissolution Test for Lipophilic Solid Dosage Forms, taking into account the aspects already mentioned (60).…”

Section: Methodological Standardizationmentioning

confidence: 99%

“…However, the instrumental set-ups used are usually conventional as discussed before and the methods presented so far have generally been used to compare specific formulations in individual experiments. Overall, methods that could be claimed to be biorelevant or even biopredictive and capable of becoming generalizable are still lacking (51).…”

Section: Biorelevance Of In Vitro Test Conditionsmentioning

confidence: 99%

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Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Klein,

Sakagami,

et al. 2023

Dissolution Technol.

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Performance testing of mucosal drug products presents the user with a multitude of challenges. Not only are there many different dosage forms to be distinguished, but also a wide variety of administration routes. The target action effect (local or systemic) is another factor to be considered. Thus, it quickly becomes apparent that there will never be a universal performance test, but the question arises just as quickly whether the method to be used should rather depend on the dosage form or the place of application, or even whether decisions must be made on an individual basis. This Stimuli article is one of a series of Stimuli articles on product performance testing, which focuses on methodological approaches and challenges in the field of performance testing of mucosal drug products. The article should be viewed as a supplement to, but also a critical discussion of the methods listed in USP general chapter Mucosal Drug Products-Performance Tests <1004>. With consideration of major physiologic aspects at the site of administration and the types of dosage forms to be studied, limitations of the methods described here and the need for methodologic updates or innovations are identified. Furthermore, suggestions are made for future activities, all aimed at developing robust, discriminatory, and meaningful test methods for the wide variety of mucosal drug products.

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Section: Methodological Standardizationmentioning

confidence: 99%

Section: Biorelevance Of In Vitro Test Conditionsmentioning

confidence: 99%

Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Klein,

Sakagami,

et al. 2023

Dissolution Technol.

View full text Add to dashboard Cite

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“…Vaginal vasculature health directly correlates to the wall thickness and is maintained by branches from the inferior vesical artery and internal pudendal artery in the lamina propia and the plexus of Santorini, draining blood into the internal iliac vein, which avoids the hepatic first-pass effect. The muscular layer and tunica adventitia provide the elongating property of the vagina and supplements from the lymphatic system, respectively [ 3 , 43 ].…”

Section: Anatomical and Physiological Features Of The Female Reproduc...mentioning

confidence: 99%

Application of Sol–Gels for Treatment of Gynaecological Conditions—Physiological Perspectives and Emerging Concepts in Intravaginal Drug Delivery

Thapa

Gurung

Parat

et al. 2022

Gels

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Approaches for effective and sustained drug delivery to the female reproductive tract (FRT) for treating a range of gynaecological conditions remain limited. The development of versatile delivery platforms, such as soluble gels (sol–gels) coupled with applicators/devices, holds considerable therapeutic potential for gynaecological conditions. Sol–gel systems, which undergo solution-to-gel transition, triggered by physiological conditions such as changes in temperature, pH, or ion composition, offer advantages of both solution- and gel-based drug formulations. Furthermore, they have potential to be used as a suitable drug delivery vehicle for other novel drug formulations, including micro- and nano-particulate systems, enabling the delivery of drug molecules of diverse physicochemical character. We provide an anatomical and physiological perspective of the significant challenges and opportunities in attaining optimal drug delivery to the upper and lower FRT. Discussion then focuses on attributes of sol–gels that can vastly improve the treatment of gynaecological conditions. The review concludes by showcasing recent advances in vaginal formulation design, and proposes novel formulation strategies enabling the infusion of a wide range of therapeutics into sol–gels, paving the way for patient-friendly treatment regimens for acute and chronic FRT-related conditions such as bacterial/viral infection control (e.g., STDs), contraception, hormone replacement therapy (HRT), infertility, and cancer.

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In-Vitro Dissolution Study protocol for various Vaginal Dosage Forms

Choudhury

Kumari

Dey

2022

RJPT

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The vaginal mucosa is well recognized as a route for delivering variety of drugs. Considerable number of anti-fertility drugs have been successfully delivered through vaginal and uterine canals. The goal of this review is to summarize the present clinical state of intravaginal medicines and IUDs, with a prime focus on the available in-vitro dissolution study methods and their importance. At present different vaginal drug delivery systems are available in the market and a few are under clinical trial. The accurate estimation drug release profile of any of such dosage form is primarily depends on the standard dissolution study protocol. The vaginal delivery system is an effective site for local and systemic drug delivery, and a range of innovative formulation strategies are being researched for its development. The concept behind the study is mainly lies on the fact that the standard dissolution protocol may vary based on formulation type, its design and its therapeutic goals.

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Vaginal and Intrauterine Delivery Systems

Cited by 3 publications

References 60 publications

Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Application of Sol–Gels for Treatment of Gynaecological Conditions—Physiological Perspectives and Emerging Concepts in Intravaginal Drug Delivery

In-Vitro Dissolution Study protocol for various Vaginal Dosage Forms

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