SPI has successfully marketed viscous pastes to global customers for over 50 years. We manufacture a range of viscous aluminum and magnesium hydroxide pastes to meet customers’ formulation needs for traditional antacid

suspensions.

Why Use Visco9 and Type M Pastes for Antacid Suspensions? y Both aluminum hydroxide and magnesium

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

y Viscous pastes yield thick and creamy formulations without the need for additional thickeners or suspending agents

y Great for traditional antacid suspension manufacturing

Making a Difference

Visco9 and Type MAluminum Hydroxide and Magnesium Hydroxide Pastes for Antacid Suspensions

Starting formulas for antacid suspensions using aluminum and magnesium hydroxide pastes

LABEL CLAIM for 10 ml

Aluminum Hydroxide (1) 400 mg Al. Hyd. Dried Gel USP (Powder form) equivalent to: 306 mg Al(OH)3 200 mg Al2O3

Magnesium Hydroxide 400 mg Mg(OH)2

Simethicone (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 Visco 9 at 14% Al(OH)3 218.57 g

Mg. Hyd Paste Type M at 30% Mg(OH)2 133.33 g

Simethicone Emulsion 30% 20.00 g

Sorbitol Solution 70% (3) 142.86 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 ml 1. Dispersion: Disperse aluminum hydroxide Visco9, magnesium hydroxide TypeM

in sorbitol and water (300 – 350 ml) using a high shear mixing device2. Blending: add hydrogen peroxide, sodium saccharin, parabens,

simethicone (optional) and flavor3. Homogenization: q.s with purified water to 1000 ml

Regulatory Compliance†

Aluminum Hydroxide Gel USP Visco 9

Magnesium Hydroxide Paste USP Type M

ü ü ASMFü ü Non-GMO

ü ü Technical File

ü ü Gluten Free

ü ü cGMP*

ü ü Tested for Elemental Impurities

ü ü Vegan

ü ü Absence of Residual Solvents

ü ü Absence of Phthalates

ü ü GRAS

ü ü Prop 65

ü ü USP

ü ü BSE/TSE

ü 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 pastes. Appearance: Thick 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: 1.00 – 1.10

Flexible for use with other APIs in various forms, our pastes can be combined with powders or pumpable gels 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 Pastes

Physical Characteristics of the suspension produced from Starting Formula

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.

Visco9 and Type MMaking a Difference

Making 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.

www.spipharma.com

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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