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Eli Lilly Retiree Proposes Test Method for Pharmaceutical Bottles

Image courtesy of Jeffrey Isaac Greenberg 6+ / Alamy Stock Photo Pharmaceuticals-liquids-Alamy-BK7XKT-ftd.jpg
A new test method for liquid oral dosage forms in container closure systems determines the moisture vapor transmission rates (MVTR) — without specifications.

During his packaging science career, Dwain L Sparks has tackled moisture vapor transmission rate (MVTR) testing issues for pharmaceuticals. Now retired from Eli Lilly and Co. and owner of Sparks Consulting Services LLC, Sparks is still actively solving challenges of the essential moisture vapor transmission rate test methods by using water in place of desiccant for solid oral dosage forms (SODF) and liquid oral dosage forms (LODF).

In 2020, the industry scored a big win when the United States Pharmacopeia (USP) approved Sparks’ test method, developed at Lilly, for measuring MVTR in water-filled pharmaceutical single-unit and unit-dose container closure systems, such as blisters. This new test method became official in USP 43 on December 1, 2020, and represents an advancement in MVTR testing vs. the desiccant-filled method.

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Now that the water-filled test method for blisters has been available for more than a year, we’d like to gauge industry’s response. Please answer a few questions in this short survey. It should take you about two minutes to complete. CLICK HERE TO GO TO SURVEY. 
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Sparks sees similar advantages in a test method for a container closure system (CCS) for LODF packaging systems that complements the existing classification, specification method in General Chapter <671>. He recently submitted a water-filled test method that can be used for all multiple-unit or bottle-style container closure systems.

“My method provides a meaningful determination of the MVTR of liquid oral dosage form container closure systems and provides a significant improvement to the outdated classification method, as well as providing a water-filled method for all dosage form container closure systems,” Sparks explains.

He developed the new test method because he has seen a LODF container closure system that failed the current method specification for “tight container.”

Sparks explains, “Stability data for a liquid drug product in this CCS indicated the suitability of the CCS in supporting a two-year shelf life. This conflicting situation brings to bare the need for an additional method for defining the permeation properties of LODF CCSs to supplement the existing specification method. Inclusion of a standalone permeation method without a specification in USP <671> has precedence in the USP established by the addition of methods for permeation without specifications for bottle and blister CCSs.”

According to Sparks, water-filled MVTR testing has numerous advantages over desiccant-filled MVTR testing of container closure systems as discussed in USP <1671>, the companion chapter to USP <671>. He enumerates a few of the advantages:

• There is no impact from a lack of mixing of the test sample contents.

• Reuse of samples is possible for an indefinite period of time, for troubleshooting and studying the same sample set at various conditions, such as 25°C/40% RH and 40°C/25% RH.

• And — most importantly according to Sparks — is “the assurance that the inside RH is always 100%, thus creating a guaranteed, steady-state pressure difference between internal and external sample environments within the sample filled with water instead of desiccant.”

At this point, Sparks can use your help to get this on USP’s agenda for this year.

To support this proposal for adding a water-filled method for LODF, as well as all multiple-unit or bottle-style container closure systems, please send your comments to USP via email at [email protected]. To help make it easy for you, Sparks has drafted petition-letter templates that you can download and use (see below). There are three versions: one for pharmaceutical manufacturers, one for packaging testing labs, and one for packaging manufacturers.

For more details about water-filled testing, contact Sparks Consulting Services LLC via email at [email protected].

 

Draft petition letter for pharmaceutical manufacturers:

March xx, 2022

 

Desmond Hunt, Ph.D., Senior Scientific Liaison

US Pharmacopeial Convention

12601 Twinbrook Pkwy

Rockville, MD  20852-1790

 

USP Packaging and Distribution Expert Committee

Re:   A New Moisture Vapor Transmission Rate Method for USP <671>

Thank you for this opportunity to submit comments to the USP Packaging and Distribution Expert Committee.  The reason for submitting this letter is in response to a discussion with Dwain L Sparks of Sparks Consulting Services LLC.

We understand that the primary focus of Mr. Sparks’ proposal is to complement the existing classification weight loss method, Classification Based on Water Method for Liquid Oral Dosage FormsScientists at COMPANY have reviewed the proposed method and determined that the method is suitable for the determination of the moisture vapor transmission rate (MVTR) of both liquid and solid dosage form packaging systems.  That is, this method is also suitable for the determination of MVTR for multiple-unit packaging systems for solid dosage forms, using water in place of desiccant.  Overall, providing this alternative method (water in place of desiccant) for all packaging systems is critical to the industry.  Please consider the following:

  1. Establishment of a USP method which accurately characterizes the MVTR of a liquid dosage form packaging system, instead of (or in addition to) a classification method which invokes a specification[1], is requisite for a complete and thorough reference to the USP.
  2. It is the responsibility of our clients, e.g., packaging manufacturers and drug application sponsors to establish the characteristics of their qualified packaging system to support their claims rather than meeting an obligatory specification, which cannot define adequate protection.
  3. Compliance with USP packaging system testing is incumbent on our clients; therefore, a new characterization method for liquid dosage form packaging systems is essential.
  4. Using water in place of desiccant for the determination of MVTR in container closure systems has the same advantages described in USP <1671> for blister packaging systems.[2]

If a formal or informal evaluation of the method is planned, e.g., a round-robin study, COMPANY requests the opportunity to participate.  Thank you for providing this opportunity to provide our perspective on this proposed method.  We trust that USP will take this input into thoughtful consideration and promptly review the proposal by Sparks Consulting Services.

Please send your comments or questions about this letter to NAME.

COMPANY

NAME

TITLE

EMAIL

O: 

M: 


[1]      The packaging systems are classified as “tight” if NMT 1 of the 10 test containers exceeds 2.5%/year...of water weight loss and does not exceed 5.0%/year in any of them.

[2]      USP General Chapter <1671> The Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems.

 

Draft petition letter for packaging testing labs:

March xx, 2022

 

Desmond Hunt, Ph.D., Senior Scientific Liaison

US Pharmacopeial Convention

12601 Twinbrook Pkwy

Rockville, MD  20852-1790

 

USP Packaging and Distribution Expert Committee

Re:   A New Moisture Vapor Transmission Rate Method for USP <671>

Thank you for this opportunity to submit comments to the USP Packaging and Distribution Expert Committee.  The reason for submitting this letter is in response to a discussion with Dwain L Sparks of Sparks Consulting Services LLC.

We understand that the primary focus of Mr. Sparks’ proposal is to complement the existing classification weight loss method, Classification Based on Water Method for Liquid Oral Dosage FormsScientists at COMPANY have reviewed the proposed method and determined that the method is suitable for the determination of the moisture vapor transmission rate (MVTR) of both liquid and solid dosage form packaging systems.  That is, this method is also suitable for the determination of MVTR for multiple-unit packaging systems for solid dosage forms, using water in place of desiccant.  Overall, providing this alternative method (water in place of desiccant) for all packaging systems is critical to the industry.  Please consider the following:

  1. Establishment of a USP method which accurately characterizes the MVTR of a liquid dosage form packaging system, instead of (or in addition to) a classification method which invokes a specification[1], is requisite for a complete and thorough reference to the USP.
  2. It is the responsibility of our clients, e.g., packaging manufacturers and drug application sponsors to establish the characteristics of their qualified packaging system to support their claims rather than meeting an obligatory specification, which cannot define adequate protection.
  3. Compliance with USP packaging system testing is incumbent on our clients; therefore, a new characterization method for liquid dosage form packaging systems is essential.
  4. Using water in place of desiccant for the determination of MVTR in container closure systems has the same advantages described in USP <1671> for blister packaging systems.[2]

If a formal or informal evaluation of the method is planned, e.g., a round-robin study, COMPANY requests the opportunity to participate.  Thank you for providing this opportunity to provide our perspective on this proposed method.  We trust that USP will take this input into thoughtful consideration and promptly review the proposal by Sparks Consulting Services.

Please send your comments or questions about this letter to NAME.

COMPANY

NAME

TITLE

EMAIL

O: 

M: 

 

[1]      The packaging systems are classified as “tight” if NMT 1 of the 10 test containers exceeds 2.5%/year...of water weight loss and does not exceed 5.0%/year in any of them.

[2]      USP General Chapter <1671> The Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems.

 

Draft petition letter for packaging manufacturers:

March xx, 2022

Desmond Hunt, Ph.D., Senior Scientific Liaison

US Pharmacopeial Convention

12601 Twinbrook Pkwy

Rockville, MD 20852-1790

 

USP Packaging and Distribution Expert Committee

Re:    Moisture Vapor Transmission Rate Determinations for Solid and Liquid Dosage Forms Per USP <671>

Thank you for this opportunity to submit comments to the USP Packaging and Distribution Expert Committee. The reason for our sending this letter is in response to a proposal by Dwain L Sparks, Sparks Consulting Services LLC, to add an additional method to USP General Chapter <671> Containers-Performance Testing.

COMPANY has commissioned the execution of the existing USP methods for desiccant-filled solid dosage form packaging systems and water-filled liquid dosage form packaging systems with a contract lab. COMPANY found the test results to be suitable for the determination of the moisture vapor transmission rate (MVTR) of our packaging systems. We understand that the primary purpose of Mr. Sparks’ proposal is to complement the existing classification weight loss method, Classification Based on Water Method for Liquid Oral Dosage Forms. However, we support his broader proposal to add this method for the determination of MVTR for both of our packaging systems, i.e., solid and liquid dosage forms, using water in place of desiccant. Overall, providing this alternative method (water in place of desiccant) is very beneficial to us because of the barriers in the preparation, handling, storage, and transporting of desiccant filled samples. We expect that other packaging manufacturers, internationally, will find the same benefits.

If a formal or informal evaluation of the method is planned, e.g., a round-robin study, COMPANY requests the opportunity to participate by providing container closure systems for solids and liquids. We trust that USP will take this input into thoughtful consideration and promptly review the proposal by Sparks Consulting Services.

Thank you for considering our comments on this proposal. Please send your questions about this letter to NAME.

COMPANY

Name

Title

email

Phone: xxx

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