Simultaneous analysis of the H1-antihistamine acrivastine and the decongestant pseudoephedrine hydrochloride by high-performance liquid chromatography

Q3 · MEDICINE

Article

Author: Li, Hongtao ; Simons, Keith J. ; Gu, Xiaochen ; Simons, F. Estelle R. ; MacNair, Kyle R.

High-performance liquid chromatography (HPLC) was used for the simultaneous quantification of the H(1)-antihistamine acrivastine and the decongestant pseudoephedrine hydrochloride. Both compounds were detected at the wavelength of 214 nm. The influence of the mobile phase and the detection wavelength was evaluated and optimized. This method was used to assay various samples from studies of the commercial preparation Semprex-D capsules. The method was found to be accurate, specific, selective, rapid, and versatile for use in routine quality control analyses.

01 Jan 2004·Drug Development and Industrial PharmacyQ4 · MEDICINE

Evaluation and Comparison of Five Matrix Excipients for the Controlled Release of Acrivastine and Pseudoephedrine

Q4 · MEDICINE

Article

Author: Daryl J Fediuk ; Keith J Simons ; F Estelle R Simons ; Xiaochen Gu

For treatment of allergic rhinitis, acrivastine with pseudoephedrine in Semprex-D conventional capsules requires dosing every 6-8 hours. This study was designed to develop a controlled release matrix tablet of acrivastine and pseudoephedrine and evaluate 5 different matrix excipients for their in vitro controlled-release profiles. Compritol 888ATO, Eudragit RS, Methocel K100M, Polyox WSR301 and Precirol ATO5 were used alone or in varying combinations for the formulation of controlled release matrix tablets. In vitro drug dissolution and mathematical modeling were used to characterize drug release rate and extent. All tablet formulations yielded quality matrix preparations with satisfactory tableting properties. Due to the aqueous solubility of pseudoephedrine and the size of the dose, none of the matrix excipients used alone prolonged drug release significantly to meet the desired twice-daily administration frequency. The use of two excipients in combination, however, significantly decreased the dissolution rate of both active ingredients. A combined lipid-based Compritol and hydrophilic Methocel produced optimal controlled drug release for longer than 8 hours for both acrivastine and pseudoephedrine.

01 May 1996·Annals of Allergy, Asthma & ImmunologyQ2 · MEDICINE

Efficacy of Acrivastine Plus Pseudoephedrine for Symptomatic Relief of Seasonal Allergic Rhinitis Due to Mountain Cedar

Q2 · MEDICINE

Article

Author: Heyward Hull ; Benjamin O Williams ; Paul McSorley ; Ronald L Sanders ; Michael F Frosolono

BACKGROUNDAcrivastine is a second-generation H1-antagonist chemically related to triprolidine, but more polar and with less central nervous system penetration than triprolidine.OBJECTIVEThe efficacy of the antihistamine-decongestant combination product (Semprex-D capsules) containing acrivastine 8 mg plus pseudoephedrine HCl 60 mg was evaluated for the treatment of seasonal allergic rhinitis symptoms.METHODSA total of 676 patients sensitive to mountain cedar pollen was enrolled into a 6-center, randomized, double-blind, placebo-controlled, parallel, 4-group study designed to compare acrivastine + pseudoephedrine, acrivastine, pseudoephedrine, and placebo. Patients with demonstrable diary symptom scores at baseline took study medication (4 doses/day) and recorded symptom scores twice daily for 2 weeks. The effectiveness of the acrivastine + pseudoephedrine combination was examined relative to the individual components and placebo in terms of changes in diary symptom scores.RESULTSOver the 2-week period, the combination of acrivastine plus pseudoephedrine was significantly more effective than (1) acrivastine, pseudoephedrine, and placebo (P < .001) for relief of all symptoms; (2) pseudoephedrine (P < .001) for relieving allergy symptoms, ie, running nose, sneezing, itchy nose/throat and tearing; and (3) acrivastine (P < .001) for reducing nasal congestion. Relative to placebo, small increases in adverse experience rates were observed with acrivastine + pseudoephedrine for dry mouth, insomnia, somnolence, and headache.CONCLUSIONThese findings in a large clinical trial demonstrate (1) the efficacy of acrivastine and (2) that each component of the combination of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to the overall efficacy, thereby supporting the conclusion that the combination is rational, safe, and effective for the treatment of allergic rhinitis.

100 Deals associated with Acrivastine/Pseudoephedrine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
-	Acrivastine/Pseudoephedrine Hydrochloride	R01BA52	-

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