Stability of Insulin Preparations

Pingel, M.; Vølund, Aa.

doi:10.2337/diab.21.7.805

Cited by 40 publications

(28 citation statements)

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“…9 Our results were obtained under somewhat different circumstances, in that each insulin bottle was exposed to outside air and insulin removed twice daily during the sixweek storage period, and in the patients, during a two-month period. Our results and those obtained by others under laboratory conditions 1,2,7,8 do not support the need for the storage recommendations of some insulin manufacturers, 8,10,11 which recommend storage at temperatures of between 2 and 8°C, and suggest that the insulin may then only be used for up to one month.…”

Section: Discussioncontrasting

confidence: 95%

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Storing Insulin in a Clay Pot in the Desert Causes no Loss of Activity: A Preliminary Report

et al. 1999

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The biological activity of insulin, like any protein, is affected if stored at extremes of temperature. The older, acidic form of insulin required refrigeration at 2 to 8°C, but the newer neutral formulation is much more stable at room temperature (15-30°C).1,2 Manufacturers recommend storing insulin under cool, shaded conditions, neither of which is available in the desert, where temperatures frequently exceed 40°C, thus constituting a major problem for diabetic patients. The possibility of adverse side effects due to heat-induced breakdown of products must also be considered. The purpose of our study was to demonstrate the possible effect on the bioactivity of insulin, following storage in a zeer, a. semiporous clay pot containing water, in desert conditions. The small amounts of water that slowly seep through the walls of the zeer evaporate, using up heat, thereby cooling the remaining water. This principle is widely used in the Middle East to cool drinking water in such containers. Materials and MethodsEight physicians, aged 25-60 years of age (median age 45 years), volunteered and gave informed consent to participate in the experiment. All were healthy individuals free of any systemic diseases, and not on medications. They were allocated to the trial using a block design, which allowed partial double-blinding. Block 1 consisted of the four males and block 2 of the four females. For block 1, pre-storage insulin was used as the standard (reference) at the start of the experiment, thereby precluding blinding of both subjects and experimentors. For block 2, the reference insulin was that stored in a refrigerator at 4°C. For block 2, both the reference and zeer insulins were available at the same time, and their order of use was randomized using a coin toss. Both subjects and experimentors were blinded to the allocation in block 2. Insulin Storage ConditionNeutral human insulin was used and stored in a refrigerator at 4°C or in a zeer. This is a clay pot that is unglazed, enabling water to slowly seep through the wall and evaporate, thus lowering the temperature of the remaining water. The zeer used to store the insulin had an internal diameter of 30 centimeters and a height of 30 centimeters. A glass jar was partially filled with desert sand and put in the center of the insulin zeer. A water bath was created by adding water outside the jar to the same level as that of the sand in the glass jar. Water was added to the mark (topped up) daily from a larger water storage zeer. The zeer was closed with a clay lid and kept in the shade. An exact replica, but without water (a dry zeer), was also used to store insulin and record temperatures. Additional bottles of insulin were kept outside in the shade, in the bathroom of an air-conditioned house and in a refrigerator. A small amount of insulin (10 units) was removed twice daily from each insulin vial to simulate actual usage conditions. Temperature readings were taken on 12 separate occasions during the six-week storage period (Table 1). Insulin Sensitivity TestThe pr...

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Section: Discussioncontrasting

confidence: 95%

“…1,2,7,8 At 25°C, intact vials of both the older acidic form 1 and the newer neutral formulation 2 were stable for several months. However, at 37°C, Pingel and Volund 7 found a loss of bioactivity of 5% over five months.…”

Section: Discussionmentioning

confidence: 99%

Storing Insulin in a Clay Pot in the Desert Causes no Loss of Activity: A Preliminary Report

et al. 1999

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“…This is commonly seen in developed multiethnic countries where immigrants from developing countries tend to continue their inappropriate practice [4]. The inappropriate storage of medications eventually leads to losing their potency [5][6][7]. A good example of that is insulin when left at a high temperature in countries with hot climate.…”

Section: Introductionmentioning

confidence: 99%

“…A good example of that is insulin when left at a high temperature in countries with hot climate. Mentioning that most manufacturers advise diabetic patients to store their insulin bottles in refrigerators at 2-8°C, but not frozen, with limiting usage or storage period to 1 month at room temperature (20-25°C), otherwise excursions of glucose level can dangerously ensue [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Awareness of home drug storage and utilization habits: Saudi study

Koshok¹,

Jan²,

AL-tawil³

et al. 2017

Med-Science

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The aim of the study was to investigate the awareness of residents in Saudi Arabia toward in-home drug storage and the using habits of their medications. This is a descriptive study that involved an electronic survey about drug storage and utilization habits. It was developed, pretested, and distributed via the social media among the population in Saudi-Arabia. About 1400 persons participated in this study. Around 84.4%, 96.6% and 58.3% of participants stored their insulin syringes, antibiotic or cough-syrup after opening in there frigerator, respectively. Moreover, most of them avoided use or discard their products upon exposure to the sun or forgetting them in the car for the whole day. 87.5% disclosed that they usually check the expiration date on drug products before using and 49.7% added they always follow the instructions regarding duration-of-use compared with 45.85% who said sometimes they follow it. 99.7% of them reported that they avoid using products upon change in color or formulation. Finally, variable-correlation was found between the age distribution of participants and their responses. The results revealed that the participants exhibited promising awareness toward the in-home drug storage in Saudi Arabia

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“…Earlier studies [1][2][3][4][5][6][7], have investigated the stability of insulin in solution or suspension. This report describes the stability of crystalline insulin.…”

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confidence: 99%

Stability of the 4th International Standard for Insulin

et al. 1975

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Summary. The stability of the (W.H.O.) 4th InternationalStandard for Insulin, has been assessed by accelerated thermal degradation studies. This is a crystalline preparation of insulin, freed from proteolytic enzymes, sealed in ampoules containing air and with a moisture content of 5-6%. Of the original biological activity 95.8 (92.8-98.9; P = 0.95)% was retained after storage for 12 years in the dark at 20 ~ C and 65.7 (63.4-68.1; P= 0.95)% after 14 years at 37 ~ C. Degradation rate constants were calculated from these data for the Standard at 20 ~ C and 37 ~ C, assuming first order kinetics. The degradation constant at 37~ did not differ significantly from those found in earlier degradation studies at 37~ over shorter periods, thereby supporting the assumption that the degradation of crystalline insulin, at least at 37 ~ C, is a first order reaction. Extrapolation of these data suggests that the Standard stored at -20~ for 20 years would have retained at least 99.93% (P = 0.95) of its original activity and so for practical purposes can be considered to be stable.

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Stability of Insulin Preparations

Cited by 40 publications

References 0 publications

Storing Insulin in a Clay Pot in the Desert Causes no Loss of Activity: A Preliminary Report

Storing Insulin in a Clay Pot in the Desert Causes no Loss of Activity: A Preliminary Report

Awareness of home drug storage and utilization habits: Saudi study

Stability of the 4th International Standard for Insulin

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