A Drug Content, Stability Analysis, and Qualitative Assessment of Pharmacists’ Opinions of Two Exemplar Extemporaneous Formulations

Abstract

<jats:p>Despite a decline in the number of active pharmaceutical ingredients prepared extemporaneously using proprietary products, there remains a need for such products in the community (for example, liquid medicines for paediatrics which may be otherwise commercially unavailable). A lack of experience and quality assurance systems may have diminished pharmacist’s confidence in the extemporaneous preparation process; therefore, pharmacists were asked to prepare two proprietary products, omeprazole and amlodipine. The resulting products were characterised in terms of variability in drug quantity, stability, particle size and antimicrobial properties. Furthermore, a self-administered questionnaire was used to assess 10 pharmacists’ opinions on the perceived complexity of the extemporaneous compounding process and their overall confidence in the final extemporaneously compounded products. Drug content studies revealed that 88.5% and 98.0% of the desired drug content was obtained for omeprazole and amlodipine, respectively. Antimicrobial properties were maintained for both drugs, however variability in particle size, particularly for amlodipine, was evident between formulations. While pharmacists who partook in the study had some or high confidence in the final products, they reported difficulty formulating the suspensions. Findings from this study provide insight into pharmacists’ views on two extemporaneously prepared products and highlight the variability obtained in preparations prepared by different pharmacists.</jats:p>

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

“…Establishing standards for extemporaneous products prompts pharmacists to pay attention in the compounding process, including in the selection of raw materials, risk assessment, procedures, and quality of the products. Moreover, it is urgent for the government to establish specific guidelines for extemporaneous products to guarantee that the products are suitable and safe for patients [ 44 , 102 ].…”

Skin biomechanics: Breaking the dermal barriers with microneedles

“…Clinical trials for μND patches are different from preclinical studies. In clinical studies, the range of μND shaft length is highly regulated since the human skin is thicker compared to small animals [9,10,66]. Moreover, safety regulations are restricted to the utilisation of biocompatible polymers approved by the Food and Drug Administration (FDA), such as hyaluronic acid, gelatin, chitosan, and polyvinyl alcohol [9,10,[66][67][68].…”

“…In clinical studies, the range of μND shaft length is highly regulated since the human skin is thicker compared to small animals [9,10,66]. Moreover, safety regulations are restricted to the utilisation of biocompatible polymers approved by the Food and Drug Administration (FDA), such as hyaluronic acid, gelatin, chitosan, and polyvinyl alcohol [9,10,[66][67][68]. Even though there have been many preclinical studies in the literature on dissolving μNDs, only a small number of clinical studies have been implemented on them (Fig.…”

The role of microneedle arrays in drug delivery and patient monitoring to prevent diabetes induced fibrosis

“…Formulating drugs within MN arrays in the dry state [269] not only improves their chemical and physical stability, but removes the need for the cold chain. For MN arrays to reach their full potential and gain regulatory approval, there may be a number of requirements, which have been summarised elsewhere [90,256,270,271], though are not unique to the formulation of drugs for the treatment of diabetes. Such considerations include, but are not limited to, upscaling and mass production of MN arrays, the potential need for sterility, MN array packaging and disposal, and long-term stability of drugs, particularly biopharmaceutics, within MN arrays.…”