Pholcodine 1.5mg/5ml / Promethazine 1.5mg/5ml oral solution sugar free

BACKGROUND: Neuromuscular blocking agents (NMBAs) are among the leading cause of perioperative anaphylaxis, and most of these reactions are IgE mediated. Allergic sensitisation induced by environmental exposure to other quaternary ammonium-containing compounds, such as pholcodine, has been suggested. The aim of this study was to assess the relationship between pholcodine exposure and NMBA-related anaphylaxis. METHODS: ALPHO was a multicentre case-control study, comparing pholcodine exposure within a year before anaesthesia between patients with NMBA-related perioperative anaphylaxis (cases) and control patients with uneventful anaesthesia in France. Each case was matched to two controls by age, sex, type of NMBA, geographic area, and season. Pholcodine exposure was assessed by a self-administered questionnaire and pharmaceutical history retrieved from pharmacy records. The diagnostic values of anti-pholcodine and anti-quaternary ammonium specific IgE (sIgE) were also evaluated. RESULTS: Overall, 167 cases were matched with 334 controls. NMBA-related anaphylaxis was significantly associated with pholcodine consumption (odds ratio 4.2; 95% confidence interval 2.3-7.0) and occupational exposure to quaternary ammonium compounds (odds ratio 6.1; 95% confidence interval 2.7-13.6), suggesting that apart from pholcodine, other environmental factors can also lead to sensitisation to NMBAs. Pholcodine and quaternary ammonium sIgEs had a high negative predictive value (99.9%) but a very low positive predictive value (<3%) for identifying NMBA-related reactions. CONCLUSIONS: Patients exposed to pholcodine 12 months before NMBA exposure have a significantly higher risk of an NMBA-related anaphylaxis. The low positive predictive values of pholcodine and quaternary ammonium sIgEs precludes their use to identify a population with a high risk of NMBA-related anaphylaxis. CLINICAL TRIAL REGISTRATION: NCT02250729.

Abstract licence: CC BY-NC-ND

Representative plot of CMC of the TTAB + PMH (3 mmol kg −1 ) system vs. ammonium salt contents at 303.15 K.

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Fast-dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. This facilitates the rapid absorption in the oral cavity and reduces first-pass effects. The aim of this study is to formulate and evaluate the Fast dissolving Oral film of Promethazine hydrochloride as a strong antihistamine which are used to reduce nausea, motion sickness and improved bioavailability of drugs as compared to conventional solid oral dosage forms. The films were prepared Hydroxy propylmethyl cellulose E15 as a film base synthetic polymer and PEG400 (Poly Ethylene Glycol 400) as a plasticizer by solvent casting method. SLS (Sodium Lauryl Sulfate) and MCC (Micro Crystalline Cellulose) used as a surfactant in different concentration. Sucrose used as a sweetening agent and strawberry as a flavoring agent. Films were found to be satisfactory when evaluated for thickness, weight uniformity, in-vitro drug release, folding endurance, drug content and disintegration time. The surface pH of all the films was found to be neutral or minor change. Films in vitro drug release studies also done by using USP dissolution apparatus. The in vitro drug release in optimized formulation F2 was found to be 14.36% in 2 min. The optimized formulation F2 also showed satisfactory pH, drug content (97.41±0.54%), effective in vitro drug release (96.03±0.68% in 16 min), disintegration time of 09 seconds and satisfactory stability.The Promethazine hydrochloride fast dissolving oral film was formulated. The given film disintegrates within nine seconds which release drug rapidly and gives action.

Abstract licence: CC BY-SA

Promethazine hydrochloride (PMZ), a potent H1-histamine blocker widely used to prevent motion sickness, dizziness, nausea, and vomiting, has a bitter taste. In the present study, taste masked PMZ nanocapsules (NCs) were prepared using an interfacial polycondensation technique. A one-step approach was used to expedite the synthesis of NCs made from a biocompatible and biodegradable polyamide based on l-arginine. The produced NCs had an average particle size of 193.63 ± 39.1 nm and a zeta potential of −31.7 ± 1.25 mV, indicating their stability. The NCs were characterized using differential scanning calorimetric analysis and X-ray diffraction, as well as transmission electron microscopy that demonstrated the formation of the NCs and the incorporation of PMZ within the polymer. The in vitro release study of the PMZ-loaded NCs displayed a 0.91 ± 0.02% release of PMZ after 10 min using artificial saliva as the dissolution media, indicating excellent taste masked particles. The in vivo study using mice revealed that the amount of fluid consumed by the PMZ-NCs group was significantly higher than that consumed by the free PMZ group (p < 0.05). This study confirmed that NCs using polyamides based on l-arginine and interfacial polycondensation can serve as a good platform for the effective taste masking of bitter actives.

Abstract licence: CC BY