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Cited by 5Thyroid Disorders and TreatmentsAdvanced Drug Delivery SystemsDrug Solubulity and Delivery Systems

Pharmaceutical studies of levothyroxine sodium hydrate suppository provided as a hospital preparation

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Hamada, Yuhei, Masuda, Kazushi, Okubo, Masato, Nakasa, Hiromitsu, Sekine, Yuko, Ishii, Itsuko·2015·Biological & Pharmaceutical Bulletin
DOI 10.1248/bpb.b14-00721
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Abstract

The levothyroxine sodium hydrate suppository (L-T4-suppository) is provided as a hospital preparation for the treatment of hypothyroid patients with dysphagia in Japan because only oral preparations of levothyroxine sodium (L-T4) are approved for the treatment of hypothyroidism. However, it has been found that serum thyroxine and triiodothyronine levels do not increase as expected with the hospital preparation, requiring a higher dosage of L-T4 in the L-T4-suppository than in the oral preparations. In this study, to determine an effective thyroid gland hormone-replacement therapy for patients with dysphagia, the pharmaceutical properties of the L-T4-suppository were investigated. Suppositories containing 300 µg L-T4 in a base of Witepsol H-15 and Witepsol E-75 (ratio of 1 : 1) were prepared according to Chiba University Hospital's protocol. Content uniformity, stability, and suppository release were tested. The L-T4-suppository had uniform weight and content. The content and release property were stable over 90 d when the L-T4-suppository was stored at 4 °C and protected from light. The release rate of L-T4 increased as pH increased. However, no L-T4 was released below pH 7.2. The release rate of L-T4 decreased as temperature decreased. These findings suggest that the low level of release of L-T4 in the rectum under physiological conditions may be the cause of the low serum thyroxine and triiodothyronine levels following L-T4-suppository administration.

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Crossref · 10.1248/bpb.b14-00721

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14 of 14 references verified0 citation errors · 0 not checkable

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  • LT4 suppository content was uniform and stable over 90 days.

    “Hamada et al demonstrated that although LT4 suppository content was uniform and stable over 90 days, its release rate correlated directly with rectal pH (259).”

    From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [259]

  • LT4 suppository release rate correlated directly with rectal pH.

    “Hamada et al demonstrated that although LT4 suppository content was uniform and stable over 90 days, its release rate correlated directly with rectal pH (259).”

    From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [259]

  • A 240-minute in vitro experiment showed approximately 20% release of LT4 at pH 8.2 and undetectable release at pH <7.2.

    “A 240-minute in vitro experiment showed an ∼20% release at pH 8.2 and undetectable release at pH <7.2.”

    From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [259]

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Research works printed but not linked: 6

  1. Kurayoshi K, Kimura O, Toyoda N, Sakamoto H, Siota S, Yone- kawa M, Hoshino K, Maeta M, Kaibara N. Report of a case with transrectal administration of thyroid hormone after total esopha- gectomy combined with thyroidectomy, parathyroidectomy and pharyngo-laryngectomy for cervical esophageal cancer. Jpn. J. Gastroenterol. Surg., 24, 856-860 (1991). · DOI
  2. Nakajima Y, Takao N, Maekawa R, Terada S, Shiio Y, Ootani M, Sugiura M, Yamamura Y, Uchino K. Utility of serum TSH monitor- ing in determining optimal dose of dried thyroid rectal supposito- ries. Jpn. J. Pharm. Health Care Sci., 37, 323-325 (2011). · DOI
  3. Itoh S, Teraoka N, Matsuda T, Okamoto K, Takagi T, Oo C, Danny Kao H. Reciprocating dialysis tube method: Periodic tapping im- proved in vitro release/dissolution testing of suppositories. Eur. J. Pharm. Biopharm., 64, 393-398 (2006). · DOI
  4. Yamazaki M, Itoh S, Sasaki N, Tanabe K, Uchiyama M. Modifica- tion of the dialysis membrane method for drug release from sup- positories. Pharm. Res., 10, 927-929 (1993). · DOI
  5. Bitterman W, Spencer RJ, Huizenga KA, Shorter RG. Contact pH of rectal mucosa in humans and dogs. Dis. Colon Rectum, 12, 96-98 (1969). · DOI · Paper page
  6. Silva JE. The thermogenic effect of thyroid hormone and its clinical implications. Ann. Intern. Med., 139, 205-213 (2003). · DOI

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Related

Authors
Hamada, Y., Masuda, K., Okubo, M., Nakasa, H., Sekine, Y., & Ishii, I.
Affiliations
Chiba University (JP)
ORCID
Venue
Biological & Pharmaceutical Bulletin
Publisher
Pharmaceutical Society of Japan
Published
2015
Volume
38
Issue
4
Pages
625-628
ISSN
  • 0918-6158 (ISSN-L)
  • 1347-5215
DOI
10.1248/bpb.b14-00721
OpenAlex
W2004987261
Cited by
5
References
14
Citations by year
2026: 1 · 2023: 1 · 2022: 1 · 2020: 1 · 2018: 1
FWCI
0.29
Type
journal article
Language
en
Open access
Locations
  • Biological and Pharmaceutical Bulletin (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Keywords
suppositories, dysphagia, hypothyroidism, hospital preparations, pH-dependent release, temperature-dependent release, content uniformity, drug stability, thyroid hormone replacement
MeSH terms
Drug Compounding, Drug Stability, Drug Storage, Light, Pharmacy Service, Hospital, Suppositories, Temperature, Thyroxine, Triglycerides, Drug Liberation

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