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Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea.

ABSTRACT: Antibiotics are commonly reported as being substandard or falsified in low- to middle-income countries, having potential to contribute to the development of antimicrobial resistance and drug-resistant infections. Amoxicillin, used to treat a number of infections and listed by the WHO as an essential medicine, presented as a good drug candidate for this study. We aimed to measure the prevalence of substandard and falsified amoxicillin oral products (tablets, capsules, and suspensions) in the National Capital District of Papua New Guinea (PNG). These oral products were surveyed in 2018 and 2019 from retail pharmacies, private and public health facilities, and the Area Medical Store, representing more than 90% of licensed medicine outlets. The product packaging was visually inspected, and the samples were analyzed for amoxicillin content using a validated high-performance liquid chromatography method. Although no falsified products were identified, 15% of the 190 products analyzed contained substandard amounts of amoxicillin. Quality varied with the dosage form (P = 0.002), with capsules exhibiting the lowest incidence of substandard content (4% in 2019) and tablets collected in 2018 experiencing the highest failure rate (50%). Suspension (40%) quality was compromised by failure to achieve homogeneity on reconstitution. A higher incidence of substandard content (P = 0.002) was associated with one major retail group. Routine testing of medicines by resource-poor countries is often unachievable, leading to the circulation of poor quality drugs, which is a global public health concern. Our study highlighted that substandard amoxicillin oral products are indeed prevalent in the NCD of PNG.

SUBMITTER: Robertson SG

PROVIDER: S-EPMC8274755 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Superparamagnetic iron oxide nanoparticles (SPIONs) generate heat upon exposure to an alternating magnetic field (AMF), which has been studied for hyperthermia treatment and triggered drug release. This study introduces a novel application of magnetic hyperthermia to induce amorphization of a poorly aqueous soluble drug, celecoxib, in situ in tablets for oral administration. Poor aqueous solubility of many drug candidates is a major hurdle in oral drug development. A novel approach to overcome this challenge is in situ amorphization of crystalline drugs. This method facilitates amorphization by molecular dispersion of the drug in a polymeric network inside a tablet, circumventing the physical instability encountered during the manufacturing and storage of conventional amorphous solid dispersions. However, the current shortcomings of this approach include low drug loading, toxicity of excipients, and drug degradation. Here, doped SPIONs produced by flame spray pyrolysis are compacted with polyvinylpyrrolidone and celecoxib and exposed to an AMF in solid state. A design of experiments approach was used to investigate the effects of SPION composition (Zn0.5Fe2.5O4 and Mn0.5Fe2.5O4), doped SPION content (10-20 wt %), drug load (30-50 wt %), and duration of AMF (3-15 min) on the degree of drug amorphization. The degree of amorphization is strongly linked to the maximum tablet temperature achieved during the AMF exposure (r = 0.96), which depends on the SPION composition and content in the tablets. Complete amorphization is achieved with 20 wt % Mn0.5Fe2.5O4 and 30 wt % celecoxib in the tablets that reached the maximum temperature of 165.2 °C after 15 min of AMF exposure. Furthermore, manganese ferrite exhibits no toxicity in human intestinal Caco-2 cell lines. The resulting maximum solubility of in situ amorphized celecoxib is 5 times higher than that of crystalline celecoxib in biorelevant intestinal fluid. This demonstrates the promising capability of SPIONs as enabling excipients to magnetically induce amorphization in situ in oral dosage forms.

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Project description:BackgroundSince 2004, the Global Fund-supported National Malaria Control Programme of Papua New Guinea (PNG) has been implementing country-wide free long-lasting insecticidal net (LLIN) distribution campaigns. In 2009, after the first distribution, only 32.5% of the population used a LLIN, mainly due to an insufficient number of nets available. This study investigated changes in mosquito net ownership and use following the continued free distribution of LLINs across PNG.MethodsFive villages from each province and 30 households from each village were randomly sampled in a country-wide household survey in 2010/11. A structured questionnaire administered to household heads recorded information on mosquito net ownership and use alongside household characteristics. Revised ownership and access indicators were applied in the analysis to reveal coverage gaps.ResultsThe survey covered 1,996 households in 77 villages. Ownership of at least one LLIN was reported by 81.8% of households, compared to 64.6% in 2009 (P?=?0.002). Sufficient LLINs to cover all household members (one net per two people) were found in 41.3% of the households (21.4% in 2009, P?<?0.001). Of all household members, 61.4% had access to a LLIN within their household (44.3% in 2009 P?=?0.002), and 48.3% slept under a LLIN (32.5% in 2009, P?=?0.001). LLIN use in children under five years amounted to 58.2%, compared to 39.5% in 2009 (P?<?0.001). Significant regional differences in coverage and changes over time were observed. A recent LLIN distribution was a key determinant of LLIN ownership (adj. OR?=?3.46) while families in high quality houses would frequently not own a LLIN (adj. OR?=?0.09). Residents were more likely to use LLINs than household guests (OR?=?2.04).ConclusionsRepeated LLIN distribution has led to significant increases in mosquito net ownership and use with few regional exceptions. Additional nets are required in areas where access is low, while major efforts are required to encourage the use of existing nets in region where access is high but use remains low. Complementary vector control approaches should also be considered in such settings.

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Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea.

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