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Evaluation of Bioequivalence Between the New Procaterol Hydrochloride Hydrate Dry Powder 26/10/2019

Procaterol hydrochloride hydrate (procaterol) is a β2‐adrenergic receptor agonist that induces a strong bronchodilatory effect. The procaterol dry powder inhaler (DPI) has been frequently used in patients with bronchial asthma or chronic obstructive pulmonary disease. We evaluated the bioequivalence and safety between the new procaterol DPI (new DPI) and the approved procaterol DPI (approved DPI). This study was a randomized, double‐blind, double‐dummy, crossover comparison to evaluate the pharmacodynamic equivalence of the new DPI and the approved DPI in patients with bronchial asthma. Primary efficacy variables were area under the concentration‐time curve (AUC) forced expiratory volume in the first second (FEV1)/h and maximum FEV1 during the 480‐minute measurement period. Patients were divided into 2 groups, New‐DPI‐First (n = 8) and Approved‐DPI‐First (n = 8), according to the investigational medical product that was administered first. Patients inhaled 20 μg of procaterol in each period. FEV1 was measured by a spirometer at predose and at 15, 30, 60, 90, 120, 180, 240, 360, and 480 minutes after each investigational medical product administration. Equivalence was evaluated by confirming that the 2‐sided 90%CIs for the difference between the new and the approved DPI in means of AUC (FEV1)/h and maximum FEV1 were within the acceptance criteria of –0.15 to 0.15 L. The difference in means of AUC (FEV1)/h and maximum FEV1 was 0.041 L and 0.033 L, respectively, and the 90%CI was 0.004 to 0.078 L and –0.008 to 0.074 L, respectively. These CIs were both within the acceptance criteria. The new DPI was assessed as being bioequivalent to the approved DPI.Procaterol HCl powder

Inhaled drugs are the most common and effective therapy in the management of bronchial asthma or chronic obstructive pulmonary disease (COPD). Short‐acting β2‐agonists are known as rescue or relief medications for asthma or COPD symptoms. Procaterol hydrochloride hydrate (8‐hydroxy‐5‐{(1RS,2SR)‐1‐hydroxy‐2‐[(1‐methylethyl)amino]butyl}quinolin‐2(1H)‐one monohydrochloride hemihydrate) is a β2‐adrenergic receptor agonist synthesized by Otsuka Pharmaceutical Co, Ltd, in 1973. It binds highly selectively to β2‐adrenergic receptors in bronchial smooth muscle cells, and a small dose of this drug induces a strong bronchodilatory effect.1, 2 A variety of formulations have been developed for this drug since the first launch of its tablet formulation in 1980. Currently marketed formulations including dry powder inhaler (DPI) and pressurized metered dose inhaler (pMDI) have been clinically useful, mainly in Asia. The effects of these inhalants are immediate, providing a good adaptation for sudden or new symptoms of asthma or COPD.

DPIs are easier to use than pMDIs because there is no need to coordinate actuation and inhalation. In addition, because DPIs do not contain environmentally unfriendly propellants,3 it is thought that DPIs are adaptive to future global environmental regulations. However, DPIs are available in many different designs, and DPIs that require many operational steps may mislead patients to inadequate inhalation of the drug. It is obvious that incorrect usage of inhaler devices has a considerable influence on the clinical effectiveness of the delivered drug.3 Clickhaler® (an approved DPI device) has hallmarked the effective uniformity and consistency of the delivered dose and fine particle fraction over a range of inspiratory flow rates4; however, patients are required to perform several steps to inhale the drug. To improve this, a new DPI, Swinghaler® (a new DPI device) was designed that requires no shaking to dispense the correct volume of powder into the measuring cups prior to inhalation, thus reducing the operational steps, and is easier to use.5, 6 In addition, the powder inhaler and storage container of the new DPI device are integrated, making it a smaller device, which greatly improves the portability of the drug. These features are considered to be beneficial to patients, and Meptin®Swinghaler® (new DPI) is expected to ease patients’ treatment. The new DPI was granted approval in 2014 in Japan and is currently the only DPI of short‐acting β2‐agonists launched in Japan.6

The bioequivalence between the new DPI and the approved DPI in patients was unknown. Although there are no standardized methods to demonstrate in vivo bioequivalence of inhaled bronchodilators, the most practical method of showing therapeutic equivalence in vivo is by estimating their relative potencies in clinical efficacy studies using adequate methodology of comparing their bronchodilator actions.7 Hence, this study was conducted to evaluate the bioequivalence and safety between the new DPI (Otsuka Pharmaceutical Co, Ltd, Tokushima, Japan) and the approved DPI (Otsuka Pharmaceutical Co, Ltd, Tokushima, Japan) in patients with bronchial asthma.

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