首页 > 资讯 > FDA发布咀嚼片的质量属性考量要点指南草案

出自识林

2016-06-20 Lachman CONSULTANTS

6月16日，FDA发布《咀嚼片的质量属性考量要点》指南草案，用于指导企业在研发这类产品时应满足的咀嚼片预期特性和FDA需要评估的属性。该指南主要针对新药申请（NDA）、简化新药申请（ANDA）和一些化学、生产和控制（CMC）补充申请。某些对于研发信息递交的建议同样适用于研究用新药申请（IND）。咀嚼片应考虑的一些特性包括：

• 易咀嚼（太硬会引发牙齿或假牙问题）
• 味道可口（指南建议可口的味道或掩味制剂）
• 尺寸和形状适中（指南草案中引用了FDA关于《仿制药片剂和胶囊尺寸、形状和其它物理属性》的指南，表明不允许咀嚼片绕开在该指南中对尺寸和形状的要求）
• 易崩解，以最大限度的减少误吸和促进溶出

其它考虑还有：如果片剂完整吞服会怎么样，是否存在与口腔粘膜吸收相关的问题（在NDA中描述），以及一系列其它问题例如硬度、崩解和溶出，咀嚼困难指数，标签等。

FDA鼓励目前已获批咀嚼片和非上市申请咀嚼片制造商重新评估关键质量属性，并确保符合适当的规格。如果已上市咀嚼片难以咀嚼（例如，引发牙齿或假牙损伤或胃肠阻塞），FDA有理由认为其对公共健康具有特定风险，将采取适当措施降低公共健康风险。

是否需要通过NDA或ANDA研发一款咀嚼产品需要考虑很多内容。至少现在企业可以依赖这一文件，虽然还在草案阶段。

Lachman CONSULTANTS - Bob Pollock先生
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Here Is Something to Chew On
By Bob Pollock | June 19, 2016

Ever had a tablet that was too big and you wished you could chew it? Well, some immediate-release tablets are designed to be chewable and carry such designation. The Guidance, titled “Quality Attribute Considerations for Chewable Tablets” , addresses the desired features of chewable tablets and describes the attributes that FDA evaluates when developing such products either in an NDA or ANDA.

Some of the characteristics that should be considered for chewable tablets include:

• It should be easy to chew (too hard could cause problems with teeth or dentures)
• Should be palatable (the Guidance suggests a pleasant taste or a taste-masked formulation)
• Be of appropriate size and shape (the document references FDA Guidance on “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules”, which may imply that making a tablet chewable may not permit one to skirt the requirements of size and shape as outlined in that Guidance)
• Having appropriate disintegration characteristics to minimize aspiration and assist dissolution

Additional consideration such as: what happens if the tablet is swallowed whole, are there issues with buccal absorption (to be described in an NDA), and a host of other issues are described such as hardness disintegration and dissolution. chewing difficulty index, labeling, etc.

Lots to consider whether developing a chewable product through an NDA or ANDA. But at least now there is a document that firms can rely upon, albeit the document in only in draft.