开发口服可分解的标准化罗迪奥拉的提取物片
Oxana Brante1,2, Rihards Talivaldis Bagons3, Santa Niedra1,2
1Laboratory of Finished Dosage Forms, Faculty of Pharmacy, Riga Stradins University, LV-1007 Riga, Latvia.
Pharmaceuticals (Basel, Switzerland)
|September 27, 2025
概括
新的 Rhodiola rosea 提取物口服分解片 (ODT) 提供了改善患者服药的方法. 这些Rhodiola rosea (RR) ODTs提供快速分解和掩盖苦味,帮助那些吞困难的人.
科学领域:
- 药理学和植物化学
- 药物输送系统 药物输送系统
- 草药是一种草药.
背景情况:
- 罗迪奥拉 (Rhodiola rosea L.) 是一种适应性草本,由于其有化合物而具有治疗性质.
- 传统用途包括提高表现,减少疲劳,提高应激弹性.
- 传统的剂量形式带来了合规性问题,特别是在患有吞困难的患者中.
研究的目的:
- 开发和优化标准化Rhodiola rosea (RR) 根和根茎干的口服分解片 (ODT).
- 为了确保快速解体和可接受的味道,以改善患者的遵守.
- 为了保持RR提取物的植物化学完整性.
主要方法:
- 使用70%的乙醇提取RR.R.的分离化.
- 标准化干燥的RR提取物以3.0%的rosavin含量使用染色学分析.
- 通过直接压缩制定ODT,评估辅助剂的分解和口味掩饰.
主要成果:
- 优化的ODT配方 (500毫克,11毫米 ø,20%标准化RR提取物) 在3分钟内分解.
- 这些ODT有效地掩盖了RR提取物的苦味.
- 该配方符合欧洲药典对ODT的标准,保持内容统一性和植物化学完整性.
结论:
- 开发的ODT为Rhodiola rosea的口腔粘膜给药提供了一个患者友好的替代方案.
- 预计将有所改善,特别是对于那些难以吞的人群来说.
- 该ODT配方保留了标准化RR提取物的植物化学完整性和感官可接受性.
相关概念视频
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
403
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
403
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
307
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
307
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
1.6K
Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
1.6K
01:17In Vitro Drug Dissolution: Alternative Methods
198
Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
198
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
151
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
151
01:14Drug Dissolution: Requirements and Profile Comparison
246
The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
246