Formulation and evaluation of CFC free inhalers for beclomethasone dipropionate

Murthy, Talasila Eswara Gopala Krishna; Mukkala, Bala Vishnu Priya; Vattikuri, Satyanarayana

doi:10.1590/s1984-82502013000200004

Cited by 3 publications

(3 citation statements)

References 7 publications

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“…All play roles in the formation of the aerosol cloud and delivery efficiency (Smyth, 2003; Newman, 2005). They mainly depend on using different types of propellants but recently, hydrofluroalkane (HFA) propellant-based MDI formulations were developed to be used instead of chlorofluorocarbons (CFC) propellants-based formulations which were banned since 1996 as they were reported to destroy the ozone layer (Talasila et al., 2013). MDI formulations are prepared either by dissolving the drug into the HFA (such as HFA 134a and HFA 227) if it has sufficient solubility in the HFA, or using a co-solvent, usually ethanol, to increase the solubility of the drug in the HFA.…”

Section: Introductionmentioning

confidence: 99%

In-vitro and in-vivo respiratory deposition of a developed metered dose inhaler formulation of an anti-migraine drug

Abdou

Kandil²,

morsi

et al. 2019

Drug Delivery

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Enhancement of zolmitriptan bioavailability through development of micronized zolmitriptan pressurized metered dose inhaler (MDI) as an alternative to its traditional drug delivery systems. A reversed phase HPLC method for zolmitriptan determination was developed and evaluated. Micronized zolmitriptan MDI formulations were prepared using two different propellants. The prepared formulations were evaluated for mean shot weight, drug content, and leakage rate in addition to in-vitro deposition using next generation impactor where mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), fine particle dose, fine particle fraction (FPF), emitted dose (ED), and dispersibility were determined. The selected formulation was evaluated for in-vivo bronchial absorption in rats. The physicochemical characters of the prepared formulations were found to be dependent mainly on the vapor pressure of the used propellant. MDI formulation prepared with HFA 134a propellant was found to have the lowest MMAD (3.47 ± 0.65) with GSD of 2.3 ± 0.4. It also had the highest FPF (41.9), ED (89.26 ± 2.35) with dispersibility of 46.9%. This formulation, when applied to rats, resulted in faster T max (27 ± 5 min) with higher C max (1236 ± 116 ng/mL) and AUC (0-12) (3375 ± 482 ng/mL·h) over the oral tablet. Its relative bioavailability was 72.7% which was 1.25 times higher than the oral tablet relative bioavailability. Zolmitriptan MDI formulation was developed using micronized zolmitriptan powder without further modification or particle engineering. The developed formulation using HFA 134a propellant could be favorable alternative, with enhanced bioavailability, to zolmitriptan oral tablet for acute migraine treatment.

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Section: Introductionmentioning

confidence: 99%

In-vitro and in-vivo respiratory deposition of a developed metered dose inhaler formulation of an anti-migraine drug

Abdou

Kandil²,

morsi

et al. 2019

Drug Delivery

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“…There was a linear correlation between total actuation, hypothetical actuation and manufacturer recommended actuation.The correlation is strongest between total actuation and hypothetical actuation (r=0.995, p<0.001) compared to manufacturer-recommended actuation and hypothetical actuation(r=0.970, p<0.001). This nding suggests that each canister could be actuated past manufacturer's recommendation similar with a study by Talasila 3 to investigate the effect of extra actuation on dose delivery showed that canister should be packaged with extra actuation of 15-30% to deliver the required 200 metered dose as marketed by manufacturer. Table 4 compared the mean weights of the Salbutamol (GSK) obtained from a study done in European country 10 with our nding.…”

Section: Methodsmentioning

confidence: 74%

The linear regression equation for pressurised metered-dose inhaler: Using canister weight to predict balance actuation in asthma inhaler

Gunasekaran

Arif

Gunasekaran

et al. 2020

Preprint

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INTRODUCTION Pressurised metered-dose inhalers (pMDIs) are not equipped with dose counters hence the balance actuation in a canister could not be determined. Each actuation expels a considerable amount of active ingredients and excipients from a canister, thus the balance actuation remaining in a pMDI based on canister weight could be evaluated using a linear regression equation.METHODOLOGY New pMDIs of 5 active ingredients [salbutamol (GSK) 200 actuation, budesonide (Glenmark) 300 actuation, ipratropium/fenoterol (Boehringer) 200 actuation, fluticasone (GSK/innovator) 120 actuation, fluticasone (Cipla/generic) 120 actuation, and beclometasone (Ivax) 200 actuation] was weighted . using a laboratory scale (Sartorius R200D; 0.01g accuracy). Two of each pMDI were weighed after each actuation, with a 30-second inter-puff interval, and the mean weight was recorded. To minimise variability in measurements, weighing was limited to one operator. The canister was considered empty when there were no changes in weight after repeated actuation. The prediction equation (one for each pMDI) was the line of best fit through data points on the scatter plot of the number of actuations versus weight.RESULTS AND DISCUSSION There was low variability between pMDIs weights (SD: 0.03g-0.08g)] of the same active ingredients indicating manufacturing uniformity among canisters. Prediction equations were generated for each type of active ingredients, where the general equation is: Actuation remaining = Constant + β*pMDI weight.CONCLUSION This study produced a prediction equation that can be used to estimate remaining actuation in a pMDI based on its weight. Weighing medication canister could be used to measure actuation remaining in pMDIs, as well as patients’ adherence to pMDIs.

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“…After crimping and filling, the canisters were sonicated in a water bath containing cool water at 10°C for 15 minutes to check for any leakage and to ensure homogenous mixing of the contents, affix/installed the canister in Autohaler. [9][10][11]…”

Section: Formulations Preparation Methodsmentioning

confidence: 99%

A Novel Metered Dose Inhalation Formulations with Formoterol 6 Mcg and Beclomethasone 200 Mcg by Using Breath Actuated Inhaler

VP,

2024

IJPQA

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Metered spray inhalers represent a broadly utilized dosage form for delivering anti-asthmatic drugs to the pulmonary system. The drug-device combination formulation, which includes beclomethasone dipropionate (BDP) and formoterol fumarate (FF), are widely employed for the treatment of bronchial asthma and chronic obstructive pulmonary diseases (COPD). The current formulation available in the market contains both active ingredients, FF and BDP, dissolved in a mixture of hydrofluoroalkane (HFA) 134a and ethanol are commonly used together as a co-solvent. However, individuals with religious or cultural concerns may opt to avoid using inhalers containing alcohol. In such cases, they may prefer non-alcoholic alternatives that are also accessible in the market. This study presents an innovative formulation strategy for metered-dose inhalers based on HFA that are non-alcoholic in combination therapy of FF and BDP inhalers. The novelty of the recently developed formulation lies in the substitution of ethanol with PEG 1000 as a co-solvent. Additionally, PEG 1000 serves the dual function of acting as a dispersing agent, thereby stabilizing the developed formulation. Moreover, it facilitates the delivery of synergistic effects by lubricating the valve components, ensuring smooth and flawless spray performance. The assay results for FF were 99.7 and 98.4%, while for beclomethasone, they were 101.0 and 99.7%, respectively, for pMDI and breath actuated inhaler (BAI). The percentage of emitted dose was 43.7 and 44.2% for pMDI, and 42.9 and 49.8% for BAI. Overall, both the developed conventional pMDI formulations and BAI exhibited efficient performance characteristics with equivalent performance.

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Formulation and evaluation of CFC free inhalers for beclomethasone dipropionate

Cited by 3 publications

References 7 publications

In-vitro and in-vivo respiratory deposition of a developed metered dose inhaler formulation of an anti-migraine drug

In-vitro and in-vivo respiratory deposition of a developed metered dose inhaler formulation of an anti-migraine drug

The linear regression equation for pressurised metered-dose inhaler: Using canister weight to predict balance actuation in asthma inhaler

A Novel Metered Dose Inhalation Formulations with Formoterol 6 Mcg and Beclomethasone 200 Mcg by Using Breath Actuated Inhaler

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