Process for preparing metered-dose inhaler for treating respiratory diseases

Abstract

The invention relates to a prescription composition and a manufacturing process for preparing a quantitative spray inhaler, and the main components of the prescription composition can be ethylene glycol synergist, corticosteroid or a combination of the two. Its prescription is prepared into a uniform suspension dosage form, with hydrofluoroalkane (HFA) as propellant and a small amount of alcohol, polyethylene glycol (PEG) as suspending agent and particle size regulator.

Description

[0001] 【Technical field to which the invention belongs】 [0002] The invention provides a medicine-containing pressurized quantitative spray inhaler combination and a preparation method thereof. The pressurized quantitative spray inhaler is a medicine for treating respiratory related diseases such as asthma or chronic pulmonary obstruction. [0003] 【Background technique】 [0004] Pressurized Metered Dose Inhaler (pMDI) allows the inhaled drug to quickly display drug activity locally, and has lower systemic adverse reactions than oral drugs, and has been compared with dry powder inhaler (DryPowder Inhaler; DPI). It has become the most widely used mode of administration for the treatment of asthma (Asthma) or chronic obstructive pulmonary disease (Chronic Obstructive Pulmonary Disease, COPD). ), antiacetylcholine drugs (anticholinergic drugs), or a combination of the above ingredients. [0005] Since 3M developed the metered dose pressurized inhaler product with chlorofluorocar...

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Problems solved by technology

[0020] 3). A large amount of ethanol: more than 10% ethanol can completely dissolve the drug, and other excipients can be added or not. The advantage is that the uniformity of administration is very good, and the disadvantage is that the drug stability may be poor and the patient's acceptance of alcohol odor is poor Wait

[0022] 5). Very low amount of ethanol: about 0.2-2% ethanol, such as the formulation of Valois company, the advantage is that the drug is in an insoluble suspension state, and the stability of the drug is optimal, but the disadvantage is that the uniformity of administration is poor, and other conferring agents are required. Formulation assistance, and may be more difficult in the process

Therefore, in the actual mass production of prescriptions in the pharmaceutical industry, even if the contents of the prescriptions are the same, there will still be quality differences due to the difference in the mixing order of ingredients and the way of filling equipment.

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