Formulation design of oral pediatric Acetazolamide suspension: dose uniformity and physico-chemical stability study

Santoveña, Ana; Suárez-González, Javier; Martín-Rodríguez, Cristina; Fariña, José B.

doi:10.1080/10837450.2016.1175475

Cited by 8 publications

(2 citation statements)

References 25 publications

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“…In addition, teams commonly face supply shortages for commercial vehicles. Another approach avoiding the use of commercial vehicles is to focus on developing formulations using a combination of simple excipients [ 26 , 27 ].…”

Section: Discussionmentioning

confidence: 99%

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

et al. 2023

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Nicardipine hydrochloride is an anti-hypertensive drug that is used off-label to treat hypertension in children. A previous oral formulation of nicardipine hydrochloride was developed using a commercial vehicle as an excipient. However, ready-to-use vehicles are prone to supply shortages, and their composition may undergo substantial modifications. The aim of this study was to propose a new oral formulation of nicardipine hydrochloride 2 mg/mL using simple excipients. The formulation included hydroxypropylmethylcellulose, simple syrup, polysorbate 80, sodium saccharin, citrate buffer, strawberry flavor and 0.2% potassium sorbate. The uniformity of content was maintained before and after agitation. Nicardipine hydrochloride concentration assessed by HPLC-MS/MS remained above 90% for 365 days before opening and for 28 days after opening. pH and osmolality were maintained throughout the study, and no microbial contamination was observed. The uniformity of mass of the delivered doses was evaluated using four different devices. A new oral formulation of nicardipine hydrochloride 2 mg/mL was developed using simple and safe excipients. Pharmacological and clinical parameters remain to be assessed and compared with those of the previous formulation.

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Section: Discussionmentioning

confidence: 99%

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

et al. 2023

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“…For years, methods to improve the efficacy of medications have been widely studied. It is known that the efficacy of a drug depends on its dosage form and route of administration [1]. Effervescent tablets are one of these forms that have drawn the attention of many for several reasons.…”

Section: Introductionmentioning

confidence: 99%

Comparison of oral bioavailability of acetaminophen tablets, capsules and effervescent dosage forms in healthy volunteers

Fathi

Kazemi

Zahedi

et al. 2018

Current Issues in Pharmacy and Medical Sciences

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A wide variety of acetaminophen dosage forms have been administered to relieve mild to moderate pain and fever, so far. The purpose of this study was to compare the oral bioavailability in healthy volunteers, of three of these dosage forms. We included healthy volunteers in our study and divided replace with placed them into three groups: tablet, capsule and effervescent. Each dosage form contained 500 mg of acetaminophen as active material. Blood samples were taken at 0.5, 1, 2, 4 and 8-hour intervals after receiving the dose. Acetaminophen blood levels were measured using HPLC method. Data were fit in a “one-compartment PK model”, using P-Pharm 1.5 software and analyzed under statistical tests. The maximum concentrations of acetaminophen in blood samples were measured at 1h after taking the drug (6.61±3.19 μg/ml, 11.29±3.94 μg/ml and 15.25±2.54 μg/ml in groups receiving capsule, tablet and effervescent, respectively). Pharmacokinetic (PK) data analysis & modeling from the three groups showed that the half-life of acetaminophen was 140.72 min in the tablet group, 140.29 min in capsule and 132.08 min in effervescent. The area under the blood levels curve were 47.04, 40.62 and 53.11 μgmin/ml, in tablet, capsule, and effervescent groups, respectively. Statistically significant differences in PK parameters were recorded as the study replace with we compared effervescent with tablets and capsule dosage forms (p < 0.05). According to the results, the effervescent form creates better PK parameters compared with tablet and capsule forms, therefore, it is suggested replace with we suggested that this form should be administer in cases of pain and fever to achieve quick drug efficacy.

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Critical appraisal of commercially available suspending vehicles for extemporaneous compounding of cardiovascular medicines: physical and chemical stability mini review

Thrimawithana

D’Amore

Dib

et al. 2018

Pharmaceutical Development and Technology

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Formulation design of oral pediatric Acetazolamide suspension: dose uniformity and physico-chemical stability study

Abstract: This reveals that AZM must be formulated as liquid forms with a more complex system of excipients (not usually indicated in pediatrics), or otherwise solid forms capable of assuring uniformity of mass and dose for every dosage unit.

Cited by 8 publications

References 25 publications

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Comparison of oral bioavailability of acetaminophen tablets, capsules and effervescent dosage forms in healthy volunteers

Critical appraisal of commercially available suspending vehicles for extemporaneous compounding of cardiovascular medicines: physical and chemical stability mini review

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