Pharmaceutical composition
A composition and drug technology, applied in the field of medical equipment, quantitative inhaler delivery of pharmaceutical preparations, can solve the problem of unstable shelf life of pharmaceutical preparations
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example 1
[0129] A number of experiments were performed to investigate the delivery of mometasone furoate and formoterol fumarate from metered dose inhalers (MDIs) using HFA-227ea or HFA-152a as propellants after initial preparation and after storage under pressure storage conditions. In vitro aerosolization properties of hydrated pharmaceutical formulations.
[0130] Micronized mometasone furoate (0.17% w / w), micronized formoterol fumarate dihydrate (0.01% / w), ethanol (2.70% w / w) and optionally oleic acid (1.70% w / w). Oleic acid (if included) is first mixed with ethanol. Drugs were weighed directly into glass containers with ethanol or ethanol / oleic acid mixture. The mixture was then homogenized using a Silverson LS5 mixer at 4000 rpm for 20 minutes. The slurry was then dispensed into 14ml coated aluminum and stainless steel containers. A 50 μL valve (Aptar, France) was then crimped onto the container and the propellant was subsequently filled into the container through the valve ...
example 2
[0154] Storage at time zero (T=0) and at 40°C and 75% relative humidity (RH) and 25°C and 60% relative humidity (RH) with the valve closed in aluminum and steel containers for 1 month (T = 1 M) and 3 months (T = 1 M) the chemical stability of mometasone furoate and formoterol fumarate dihydrate in HFA-227ea and HFA-152a with and without oleic acid was studied.
[0155] Pharmaceutical formulations were prepared as described in Example 1 above and analyzed using the HPLC technique described in Example 1 above.
[0156] The results of the chemical stability study of the combination pharmaceutical formulations of mometasone furoate (MMF) and formoterol fumarate dihydrate (FFD) in HFA-152a and HFA-227ea are shown in Tables 6 to 9 below.
[0157] Table 6. Mometasone (MMF) / Formoterol (FFD) Formulations in HFA-227ea Containing Oleic Acid at 25°C and 60% RH and 40°C and 75% RH at Starting Time Point, T=1 months and the chemical stability values at T=3 months.
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example 3
[0169] Formulations containing mometasone furoate and formoterol fumarate dihydrate and HFA-227ea or HFA-152a were prepared in PET vials, and the suspension stability of the formulations was determined using Turbiscan MA 2000. The Turbiscan instrument has a read head moving along a flat bottom, a 5 mL cylindrical glass cell, and reads transmitted and backscattered light every 40 μm over a maximum sample height of 80 mm. The read head uses a pulsed near-infrared light source and two simultaneous detectors. The transmission detector acquires light transmitted through the suspension tube at 0°, while the backscatter detector receives light backscattered by the product at 135°.
[0170] The settling and size of the flocs of the different formulations are shown in Table 10 below.
[0171] Table 10. Suspension stability values of mometasone (MMF) and formoterol (FFD) for compound mometasone / formoterol formulations in HFA-227ea and HFA-152a with and without oleic acid (OA) .
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