Related Experiment Video

Updated: May 31, 2026

Formation of Dispersible Taohong Siwu Tablets
05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Comparison between liquid and tablet formulations in the treatment of congenital hypothyroidism

Anna Parzianello1, Erika Cantarelli2, Elisa Bortolamedi1,3

  • 1Pediatric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti 11, Bologna, 40138, Italy.

Endocrine
|May 28, 2026
PubMed

Insights

Three levothyroxine (LT4) formulations showed similar effectiveness in treating pediatric congenital hypothyroidism (CH). While some minor differences in thyroid hormone levels were noted at specific times, all treatments were safe and generally maintained target ranges.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacology
  • Genetics

Background:

  • Congenital hypothyroidism (CH) requires lifelong levothyroxine (LT4) replacement therapy.
  • Optimizing LT4 formulation is crucial for effective treatment in infants and children.
  • Various LT4 formulations exist, but comparative data in pediatric CH is limited.

Purpose of the Study:

  • To compare the efficacy and safety of three levothyroxine (LT4) formulations (tablets, oral drops, oral solution) in pediatric patients with congenital hypothyroidism (CH).

Main Methods:

  • A retrospective-prospective observational monocentric study included 82 pediatric patients diagnosed with CH.
  • Patients were categorized into three groups based on the LT4 formulation used: tablets (T), oral drops (D), or oral solution (S).
  • Thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels were monitored from diagnosis up to age 3 years.

Main Results:

  • No significant differences in overall efficacy were found between the three LT4 formulations in maintaining target TSH and fT4 levels.
  • Higher TSH concentrations were observed in the oral solution group compared to tablets at 7-15 days.
  • A higher proportion of patients in the oral drops group had sub-reference fT4 levels at 12 months.

Conclusions:

  • All three levothyroxine formulations demonstrated comparable overall effectiveness and safety in managing pediatric congenital hypothyroidism.
  • Minor transient differences in TSH and fT4 levels were observed between formulations at specific time points.
  • Further research is needed to determine the clinical significance of these transient biochemical variations.
Abstract

Keywords:
Congenital HypothyroidismLT4LevothyroxineNewborn ScreeningPediatric EndocrinologyThyroid

More Related Videos

Establishment of Rat Models Mimicking Gender-affirming Hormone Therapies06:24

Establishment of Rat Models Mimicking Gender-affirming Hormone Therapies

Published on: January 10, 2025

Generation of a Mouse Spontaneous Autoimmune Thyroiditis Model04:39

Generation of a Mouse Spontaneous Autoimmune Thyroiditis Model

Published on: March 17, 2023

Related Concept Videos

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Synthesis and Regulation of Thyroid Hormones01:20

Synthesis and Regulation of Thyroid Hormones

Low blood levels of the thyroid hormones — triiodothyronine (T3) and thyroxine (T4) — signal the hypothalamus to release the thyrotropin-releasing hormone (TRH). TRH then reaches the pituitary gland and stimulates the release of thyroid-stimulating hormone(TSH) into the bloodstream.
Upon reaching the thyroid gland, TSH stimulates the follicular cells' active uptake of iodide ions from the blood. The ions diffuse to the apical surface of the cells and are oxidized to iodine. The iodine is then...
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Oral Drug Delivery Systems: Introduction01:23

Oral Drug Delivery Systems: Introduction

Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.