Capsule Succeeds in Consistency Evaluation, Salbutamol Hydrochloride Capsule Sets New Benchmark

With the continuous advancement of consistency evaluation, in July, Epistine hydrochloride capsule, an important variety, successfully passed the evaluation, which marks a new breakthrough in the consistency evaluation process of Chinese generic drugs. For the first time, the capsule uses a different reference preparation than tablets, demonstrating China's innovation in generic drug evaluation.

Epistastine hydrochloride capsule, a drug used to treat skin psoriasis, was approved by the State Food and Drug Administration in 2020. As a new selective tyrosine kinase inhibitor, epastine hydrochloride can effectively inhibit the activity of Jak1 and Jak3. Jak signaling pathway is a key pathway that regulates immune cell activation and inflammatory response. By inhibiting the Jak pathway, epastine hydrochloride can reduce the activation of T cells, B cells and other immune cells, as well as the release of inflammatory factors, thus inhibiting the pathogenesis of psoriasis.

Epistastine hydrochloride capsule is suitable for the treatment of moderate to severe plaque psoriasis. The recommended oral dose for adults is 2mg once daily. At the beginning of treatment, the dose may be appropriately increased to 4mg each time, and subsequently adjusted according to the condition. The results of clinical trials show that epistastine hydrochloride can significantly improve the symptoms of skin lesions in patients, and the curative effect is lasting. The majority of patients can achieve the efficacy standard of PASI 75 within 12 to 16 weeks, and long-term treatment can also maintain good therapeutic effect.

Epistastine hydrochloride capsule was well tolerated, and the common adverse reactions mainly included upper respiratory tract infection, headache, rash, etc., most of which were mild. Providing a new treatment option for patients with moderate to severe psoriasis, epistastine hydrochloride capsules have shown good efficacy in improving clinical symptoms and preventing recurrence. Its application prospect in the field of psoriasis deserves our attention.

As an important part of generic drug quality control, drug consistency evaluation has become the focus of pharmaceutical industry. Since last year, the number of varieties passing the conformance assessment has continued to increase, and the quality level has also been continuously improved. In this context, the successful evaluation of epirastine hydrochloride capsules has undoubtedly set a new benchmark for other generic drug companies.

After verification, epirastine hydrochloride capsule selected the tablet preparation epirastine hydrochloride tablet as the reference preparation, breaking the usual practice of generic drugs usually choosing the same dosage form as the reference. This cross-dosage type reference strategy provides a new idea for the evaluation of other varieties and reflects the higher quality requirements of the regulatory authorities for generic drugs, which will help further promote the healthy development of China's generic drug industry.

We look forward to the emergence of more innovative evaluation strategies to continuously improve the quality of generic drugs and provide better medicines to patients.