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Stable liquid medication containing diphenhydramine

A technology of liquid medicine, diphenhydramine hydrochloride, which is applied in the field of medicine, can solve the problems of increasing packaging cost and packaging volume, making it difficult for consumers to judge medicines, and reducing the appearance of products.

Inactive Publication Date: 2016-10-26
PROCTER & GAMBLE CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These packaging requirements can increase packaging cost and volume, reduce product aesthetics, and can make it difficult for consumers to determine how much drug is left in the bottle between uses

Method used

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  • Stable liquid medication containing diphenhydramine
  • Stable liquid medication containing diphenhydramine
  • Stable liquid medication containing diphenhydramine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 contained sorbitol and had a pH of about 5.0, Example 2 contained HFCS and had a pH of about 4.0, Example 3 contained sorbitol and had a pH of about 4.0, and Examples 4 and 5 both had a pH of about 5.0 pH and contains sorbitol.

[0032] The commercial product is Dye-Free Children's Allergy (Lot No. 21772, as of April 2015) and Children's Allergy Medicine Allergy Relief (lot number 144984, as of March 2015). and The product is sold in secondary packaging which is a cardboard box. The primary packaging of the product is a translucent bottle without UV inhibitors, while The primary packaging of the product is a dark opaque bottle. The product contains the following ingredients: Active Ingredient (5 mL each, 1 teaspoon): Diphenhydramine HCI (12.5 mg). Inactive Ingredients: Sodium carboxymethylcellulose, citric acid, flavoring, glycerin, purified water, sodium saccharin, sodium benzoate, sodium citrate, and sorbitol solution. The product contains the...

Embodiment

8.00％

[0082]

[0083]

[0084] Examples 1-8 can be prepared as follows. First make the glycol premix as follows: Put the propylene glycol in a container and start stirring. The DPH, ethanol, and flavor are then added and mixed until all components are completely dissolved to form a diol premix.

[0085] The main mixture was then prepared as follows: Purified water was added to the vessel and stirring was started. Buffer salts including sodium citrate dehydrate and citric acid and surfactants including polyoxl 40 stearate were then added and stirred until dissolved. Sodium saccharin, sucralose (when present), colorants (which include FD&C Red No. 40 and FD&C Blue No. 1) and sodium benzoate were then added and stirred until dissolved to make the main mixture.

[0086] Next, add the diol premix to the premix and rinse the diol premix container with about 5 or 6 mL of purified water and add it to the main mix. The HFCS, sorbitol and / or glycerin are then added to t...

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PUM

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Abstract

A chemically stable liquid medication that contains diphenhydramine hydrochloride and has a pH of greater than about 4.5 is provided. The liquid medication contains less than about 1.5% of BZH based on parent DPH after 14 days at 75 DEG C according to the Stability Prediction Method. The liquid medication is adapted for consumption by adults and children 12 years and over.

Description

technical field [0001] The present invention relates to medicaments, and more particularly to liquid medicaments comprising diphenhydramine. Background technique [0002] Diphenhydramine hydrochloride (DPH) is a common active substance in over-the-counter medications used to treat allergic symptoms, including itching, insomnia, motion sickness, and extrapyramidal symptoms. DPH is available as both solid and liquid medications. However, it can be difficult to formulate a stable liquid DPH drug in which both the color and the DPH are stable over a period of time. [0003] Liquid medicines are bottled and stored for a considerable period of time. However, if the solution does not have the proper properties, the DPH may degrade, shortening the shelf life of the product. [0004] In addition, DPH and colorants may degrade when exposed to heat such as the warm temperatures that may be encountered during shipping, use and storage. Reducing sugars such as those present in high f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K9/00A61K47/26A61K9/08
CPCA61K47/10A61K9/0095A61K47/26A61K9/08A61K31/135A61K31/138
Inventor A·M·考夫曼R·W·库鲁门A·特拉鲍尔希T·E·许特
Owner PROCTER & GAMBLE CO