Gelatin capsule brittleness as a function of relative humidity at room temperature

Kontny, Mark J.; Mulski, Carol A.

doi:10.1016/0378-5173(89)90168-3

Cited by 55 publications

(24 citation statements)

References 6 publications

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“…In general, the brittleness of gelatin capsules has been found to increase markedly below 30%RH, which corresponds to about 10% water content. 26,27 Since the RH of storage conditions used for regulatory determination of shelf lives are higher than this, the packaging consideration is largely related to the internal components. In particular, if the RH inside the packaging is lower than about 30% (see Determination of Relative Humidity Inside Packaging Section), than there is the potential for cracking issues.…”

Section: Dissolutionmentioning

confidence: 99%

Package Selection for Moisture Protection for Solid, Oral Drug Products

Waterman

MacDonald

2010

Journal of Pharmaceutical Sciences

103

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Section: Dissolutionmentioning

confidence: 99%

Package Selection for Moisture Protection for Solid, Oral Drug Products

Waterman

MacDonald

2010

Journal of Pharmaceutical Sciences

103

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“…It has been described in literature that low relative humidity (RH) may cause capsule brittleness. 1 It is conceivable that brittle inhalation capsules get splintered during inhalation and consequently that splintered particles will reach the mouth/throat of the patient.…”

Section: Introductionmentioning

confidence: 99%

Storage Instructions for Inhalation Capsules

Renswouw

Laarhoven

Haren

et al. 2010

Journal of Pharmacy Practice

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The objective was to study the influence of storage conditions on the quality of inhalation capsules and to investigate patients' knowledge and adherence to storage instructions. Inhalation capsules marketed in the Netherlands were stored at normal (20°C/60% relative humidity) and dry (20°C/25% relative humidity) conditions during 34 days and checked for brittleness. After 1 day of storage at normal conditions, no brittleness was perceived. Longer periods and dry conditions increased the risk of brittleness. Only tiotropium capsules resisted all test situations. Subsequently, patients using inhalation capsules were sent a questionnaire in order to investigate their knowledge and actual behavior regarding storage of the capsules. Adherence to the required storage instructions was achieved by only 31.8% of all patients. Inferior storage locations turned out to be the main problem, 58.7% of the patients applied an incorrect place. Knowledge of the required storage instructions was lacking in 83.6% of all patients. It is concluded that the majority of patients store their inhalation capsules incorrectly and have insufficient knowledge of the appropriate storage conditions. Incorrectly stored capsules may become brittle and cause splintering during inhalation. The feeling of splinters in the mouth/throat may reduce the patient's confidence in the product's quality and affect compliance.

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“…The Spinhaler ® was unique for its time because it was a breath-actuated inhaler and overcame the problem of patient coordination, which provided a significant limitation with other contemporary inhalers. Gelatin capsules are generally well suited for this application; however, they become brittle if they lose moisture due to exposure to low humidities (Kotny & Mulski, 1989) or due to interaction with powder fills (Bell, Stevenson, & Cox, 1971).…”

Section: Introductionmentioning

confidence: 99%

A Comparison of the Puncturing Properties of Gelatin and Hypromellose Capsules for Use in Dry Powder Inhalers

Birchall

Jones

Morrissey³

2008

Drug Development and Industrial Pharmacy

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This study investigates capsule puncture in dry powder inhalers. Gelatin and hydroxypropylmethyl cellulose (HPMC) capsules (stored at 11 and 33% relative humidities) were punctured using a pin from a Foradil ® inhaler, with insertion force measurement via an Instron tester. In HPMC capsules, the force after capsule puncture reduced by half and then increased to a second maximum as the pin shaft entered the hole. In gelatin capsules, the postpuncture force reduced to zero, indicating shell flaps losing contact with the pin. At lower moisture contents, both capsules were less flexible. This provides a tool to measure the shell properties of inhalation capsules.

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Gelatin capsule brittleness as a function of relative humidity at room temperature

Cited by 55 publications

References 6 publications

Package Selection for Moisture Protection for Solid, Oral Drug Products

Package Selection for Moisture Protection for Solid, Oral Drug Products

Storage Instructions for Inhalation Capsules

A Comparison of the Puncturing Properties of Gelatin and Hypromellose Capsules for Use in Dry Powder Inhalers

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