LV13 and FlogelPumpable Gels for Antacid Suspensions

Aluminum hydroxide and magnesium hydroxide pumpable gels are easy to handle as you make cost effective antacid suspensions with a pleasant mouthfeel.

Why Use LV13 and Flogel Together for Antacid Suspensions? y Both APIs are easy to handle as they are

pumpable gels y Both aluminum hydroxide and magnesium

hydroxide have a fine and narrow particle size distribution resulting in a pleasant mouthfeel

y Aluminum hydroxide pumpable gel has a higher concentration compared to paste

y Less quantity required to achieve finished dose and allowing to have more concentrated formulations

y Lower overall costs - simpler, better and less expensive way to make antacid suspensions

Making a Difference

Starting formula for antacids suspensions using pumpable gels LV13 and Flogel

LABEL CLAIM for 10 ml

Aluminum Hydroxide (1) 800 mg Al. Hyd. Dried Gel USP (Powder form) equivalent to: 612 mg Al(OH)3 400 mg Al2O3

Magnesium Hydroxide 800 mg Mg(OH)2Simethicone (2) 60 mg

(1) As per USP Monograph for “Alumina, Magnesia, and Simethicone Oral Suspension”, or for “Alumina, Magnesia Oral Suspension”. “Oral Suspension may be labeled to state the aluminum hydroxide content in terms of the equivalent amount of dried aluminum hydroxide gel, on the basis that each mg of dried gel is equivalent to 0.765 mg of Al(OH)3” or equivalent to 0.500 mg of Al2O3.(2) Optional and quantity can be adjusted to desired label claim target

FORMULATION Quantities for 1,000 ml

Al. Hyd. Gel LV13 at 20% Al(OH)3 306.00 g

Mg. Hyd Gel Flogel at 30% Mg(OH)2 266.67 g

Simethicone Emulsion 30% 20.00 g

Sorbitol Solution 70% (3) 100.00 g

Xanthan Gum (pre-dispersed in water) (3) 2.00 g

Sodium Citrate 2.50 g

Sodium Saccharin (3) 2.00 g

Hydrogen Peroxide 35% (3) 0.57 g

Methyl Paraben (3) 1.00 g

Propyl Paraben (3) 0.30 g

Flavor (3) 0.10 g

Purified Water q.s to 1000 ml

(3) Quantities can be adjusted to achieve desired viscosity, sweetness, flavor and preservation levels.

Manufacturing Guidance for 1000 mlEasy manufacturing steps, no special mixer device needed

1. Blending: Blend LV13, Flogel, sodium citrate, sodium saccharin, sorbitol, simethicone (optional), hydrogen peroxide and parabens into water (0 – 100 ml)

2. Dispersion: add a suspension of Xanthan Gum at 0.5% to 1.0% and flavor3. Homogenization: q.s with purified water to 1000 ml

Regulatory Compliance† Aluminum Hydroxide Gel LV13 USP

Magnesium Hydroxide Flogel USP

ü ü ASMFü ü Non-GMOü ü Technical Fileü ü Gluten Freeü ü cGMP*ü ü Tested for Elemental Impuritiesü ü Veganü ü Absence of Residual Solventsü ü Absence of Phthalatesü ü GRASü ü Prop 65ü ü USPü ü BSE/TSEü ü Absence of Allergens

* Redacted EIR issued by USFDA is available and is equivalent to cGMP certificate.

† Documents available upon request

SPI Pharma’s expertise will help you to create antacid suspensions with cost effective, aluminum hydroxide and magnesium hydroxide pumpable gels.

Physical Characteristics of the suspension produced from Starting FormulaAppearance: Thin thixotropic white to

off-white suspension, easy to re-suspend, with gentle shake

pH: 7.0 – 8.6 (USP Monograph for Alumina, Magnesia, and Simethicone Oral Suspension)

Specific Gravity: 1.10 – 1.15

Flexible for use with other APIs in various forms, our gels can be combined with powders or pastes per the customers’ formulation needs. Contact our Technical Service team for assistance.

Figure 1 : Narrow and fine Particle Size Distribution centered on about 5 µm for a pleasant mouthfeel

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Antacid Suspension with Pumpable Gels

Elemental ImpuritiesOperating in a highly regulated industry, we understand the importance of minimal elemental impurities for our customers. We perform a thorough risk assessment on all of our products to ensure regulatory compliance. SPI Pharma has invested approximately $1M of testing technology, resources and external testing to ensure our customers the peace of mind that our products are below the threshold and only require annual confirmation testing. Customers can depend on our certification and can alleviate their burden of testing.

LV13 and FlogelMaking a Difference

All information and statements given in this brochure are believed to be accurate at the time of publication. However, neither SPI Pharma nor any of their affiliates make any representations or warranty with respect thereto, including, but not limit to, any results obtained in the processing of the products by customers or any third party. All information and statements are intended for persons having the required skill and know-how and do not relieve the customer or user from verifying the suitability of information and statements given for a specific purpose prior to use of products. It is entirely the obligation of the costumer or user to comply with applicable laws and regulations, and also with all patent or other intellectual property rights of third parties. SPI PHARMA EXPRESSLY DISCLAIMS ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND. WHETHER EXPRESS OR IMPLIED, AS TO THE ACCURACY, CURRENCY, COMPLETENESS AND/OR THE MERCHANTABILTY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY INFORMATION CONTAINED IN THIS BROCHURE AND/OR ANY PRODUCT DESCRIBED OR PROMOTED IN THIS BROCHURE, INCLUDING WARRANTIES WITH RESPECT TO INFRINGEMENT OF ANY PATENT, COPYRIGHT, OR OTHER RIGHTS OF A THIRD PARTY. We reserve the right to change product specification and not specified properties of the products without prior notice.

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Naturally Sourced MineralsOver the last 50 years, SPI Pharma has established a breadth of experience and knowledge to produce high quality magnesium products for pharmaceutical and healthcare products. In the United States many of our Magnesium Hydroxide based products originate from the Delaware Bay. This location was chosen due to the excellent quality and salinity of the seawater. Prior to pumping the seawater to our facility, it is filtered by using the natural sand bed of the bay to ensure no water life is affected by our process.What happens once the extraction process is complete? After extraction, we test the seawater to guarantee quality and return it back to the bay to support the natural ecosystem.

October 2019All rights reserved

© 2019 SPI Pharma

Making a Difference