Draft Guidance Issued on Capsule Bead Size - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Draft Guidance Issued on Capsule Bead Size

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle. Beads are often included in capsule products that contain labeling that indicates patients can break the capsule and sprinkle its internal beads on soft foods to swallow (without chewing) as an alternative administration technique. According to the document, this type of administration is common with extended- or delayed-release characteristics. The concern lies in whether patients can swallow the beads with the soft foods without chewing the product. If the beads are chewed, the drug product may be absorbed and released too quickly into the body.

The guidance specifically calls for a maximum bead size of 2.0 mm. This is based on approved product information and human studies that demonstrate food is chewed to approximately 2 mm in median particle size before swallowing. “We recognize the specific importance of a maximum size limit for modified-release products, where unintentional chewing of beads may lead to pharmacokinetic differences. It is our belief, however, that maintaining a consistent maximum size of beads for all drug products labeled for sprinkle is prudent. Taste and performance issues that may arise from inadvertently chewing beads labeled for sprinkle may lead to noncompliance and decreased drug product efficacy,” states the draft document.

The guidance also provides current FDA thinking on delivering capsule beads via an enteral feeding tube as well as its recommendations on bioavailability and bioequivalence.

In terms of submission information, the draft guidance recommends that bead-size distribution be provided in a common technical document (CTD) application, specifically in section 3.2.P.3.3 (Description of Manufacturing Process and Process Controls) or in section 3.2.P.5.1 (Specification). The maximum bead size can be provided in the CTD 3.2.P.1 (Description and Composition of the Drug Product) section or 3.2.P.4 (Control of Critical Steps and Intermediates) section.

The draft guidance does not apply to bead products already on the market, but only to applicants of new drug, abbreviated new drug, or new biologics licensing applications (NDAs, ANDAs, BLAs). “Currently approved NDAs, ANDAs, or BLAs that contain beads that are greater than the recommended 2.0 mm need not modify their product specifications (unless the product has issues that are affecting public health),” states the draft guidance. However, an ANDA that references a currently approved reference listed drug (RLD) may propose a bead size equal to or less than the size of the bead used in the currently approved RLD, according to the document. Such data should be provided to support the size(s) of the beads in the ANDA product within a CTD submission.  

Comments on the draft guidance are due within 90 days of the document’s publication.



blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here