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| FDA Guidance for Industry Practices |
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Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
October 2022 (Rev. 1)
Having looked at the growing list of Guidance Documents related to pharmaceutical compounding, we will now just look at various Guidance Documents that may apply to compounding or manufacturing. This week, we will look at one that applies to industry.
The outline of the document is as follows:
| I. | INTRODUCTION
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| II. | BACKGROUND
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| A. | Differences in Size and Shape of Tablets and Capsules between a Reference Listed Drug and a Drug Product Subject to an Abbreviated New Drug Application |
| 1. Size
2. Shape
3. Patient Factors
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| B. | Other Physical Attribute Considerations
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| III. | RECOMMENDATIONS
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| A. Size
B. Shape
C. Other Physical Attributes
D. Biowaivers |
| I. | INTRODUCTION
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Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing. While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates. The recommendations in this guidance apply to abbreviated new drug applications (ANDAs) and their supplements for additional strengths that are submitted to the Office of Generic Drugs (OGD). This guidance does not apply to approved ANDAs (generic drugs) already on the market. However, if the Agency determines that an approved product should be modified because the size or shape of a product poses a risk to public health, we will notify the holder of the ANDA. This guidance has been prepared by the Office of Generic Drugs and the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. RLD means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. See 21 CFR 314.3(b). FDA publishes the identification of RLDs in the Approved Drug Products with Therapeutic Equivalence Evaluations (i.e., Orange Book). If the manufacturer of a RLD makes a postapproval change to the size or shape of a previously approved tablet or capsule, the generic versions generally will not need to be modified. However, the Agency could ask for modifications to the product if there are safety concerns because of the differences in physical characteristics
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| II. | BACKGROUND
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| A. | Differences in Size and Shape of Tablets and Capsules between a Reference Listed Drug and a Drug Product Subject to an Abbreviated New Drug Application.
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| 1. | Size
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| 2. | Difficulty swallowing tablets and capsules can be a problem for many individuals and can lead to a variety of adverse events and patient noncompliance with treatment regimens. It is estimated that over 16 million people in the United States have some difficulty swallowing, also known as dysphagia. For these individuals, swallowing a tablet or a capsule can be particularly challenging. A survey of adults on difficulties swallowing tablets and capsules suggests that this problem goes well beyond the patient population with clinically recognized dysphagia and may affect as many as 40 percent of Americans. Of those who experience difficulty swallowing medications, less than a quarter discuss the problem with a healthcare professional, 8 percent admit to skipping a dose of prescribed medication, and 4 percent have discontinued therapy because the tablets and/or capsules were difficult to swallow. Individuals who find it difficult to swallow tablets and capsules frequently cite the size as the main reason for the difficulty in swallowing. Size and shape of tablets and capsules affect the transit of the product through the pharynx and esophagus and may directly affect a patient's ability to swallow a particular drug product. Larger tablets and capsules have been shown to have a prolonged esophageal transit time. This can lead to disintegration of the product in the esophagus and/or cause injury to the esophagus, resulting in pain and localized esophagitis and the potential for serious sequelae including ulceration, stricture, and perforation. Other adverse events such as pain, gagging, choking, and aspiration are related to swallowing difficulties in the oropharyngeal phase of swallowing and increasingly occur with larger tablet and capsule sizes. |
Next week, we will continue looking at this specific Guidance Document.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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FDA Panel Recommends Pulling Makena Off the Market
The FDA will soon decide on whether to pull Makena (Hydroxyprogesterone caproate Injection) due to questions about its efficacy and safety. As you recall, it was compounded for decades until Covis Pharma fast-tracked it through the FDA 11 years ago and compounding ceased. This action may put many women at risk without an approved drug for preterm birth.
Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular (vials) or subcutaneous (auto-injector) injection. Each 1.1-mL Makena auto-injector for subcutaneous use and each 1-mL single-dose vial for intramuscular use contains Hydroxyprogesterone Caproate USP, 250 mg/mL (25% w/v), in a preservative-free solution containing Castor Oil USP (30.6% v/v) and Benzyl Benzoate USP (46% v/v). Each 5-mL multi-dose vial contains Hydroxyprogesterone Caproate USP, 250 mg/mL (25% w/v), in Castor Oil USP (28.6%), and Benzyl Benzoate USP (46% v/v) with the preservative Benzyl Alcohol NF (2% v/v).
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Did You Know (On Government) ...
...the following?
"And the Toastmaster said, 'Welcome to the luncheon Senator. We all want to hear the dope from Washington.'"
"A political plank is what a candidate stands on before election and sits on afterward."
"Admirer to political candidate: 'Great speech sir! I really like the way you dodged those issues!'"
"What this country needs is fewer people who think they know what this country needs."
"A municipal official says he ran for office because he thought his possible opponent, if successful, might be even more corrupt than he was."
"There is no doubt this is a land of promise-when you hear the candidates who are seeking votes of the people."
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Thoughts for the Week (On Government)
"Old politicians never die, they just run once too often!"
"In the old days it was 2 chickens in every pot, and now it is two government employees for every taxpayer!"
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Tell them they can get their own free copy of the weekly Compounding Today newsletter at
https://CompoundingToday.com/Newsletter/
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From Out of the Past
Drove too long
Driver Snoozing
What happened next,
Is not
Amusing!
Burma-Shave
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